Heart FailurePhase 3GALACTIC-HFNCT02929329

Registrational Study With Omecamtiv Mecarbil (AMG 423) to Treat Chronic Heart Failure With Reduced Ejection Fraction

A Phase 3 study testing Omecamtiv Mecarbil in people with Heart Failure, run by Cytokinetics at 1,033 sites in 36 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if treatment with omecamtiv mecarbil when added to standard of care is well tolerated and superior to placebo in reducing the risk of cardiovascular death or heart failure events in adults with chronic heart failure with reduced ejection fraction (HFrEF). Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Heart Failure
What is being tested?: Omecamtiv Mecarbil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8,256 participants
Where: 1,033 sitesin 36 countries
Study dates: 6 Jan 2017to 14 Sep 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject has provided informed consent
Male or female, ≥ 18 to ≤ 85 years
History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
New York Heart Association (NYHA) class II to IV at most recent screening assessment.
Managed with HF standard of care (SoC) therapies consistent with regional clinical practice guidelines according to investigator judgment of subject's clinical status

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Current hospitalization with primary reason of HF OR one of the following events within 1 year of screening: hospitalization with primary reason of HF; urgent visit to emergency department (ED) with primary reason of HF.
Elevated B-type natriuretic peptide (BNP) or n-terminal-prohormone brain natriuretic peptide (NT-proBNP)
Other Inclusion Criteria May apply

Who cannot join

Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
Subject has known sensitivity to any of the products or components to be administered during testing
Other Exclusion Criteria May apply

Trial locations and contacts

1,033 sites in 36 countries.

Country

City, postcode or hospital

1023 sites in 36 countries

United States300 sites

Research Site
‘Aiea, Hawaii, 96701
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Abington, Pennsylvania, 19001
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Albany, New York, 12208
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Albuquerque, New Mexico, 87106
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Alexandria, Louisiana, 71301
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Altamonte Springs, Florida, 32714
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Altoona, Pennsylvania, 16602
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Amarillo, Texas, 79106
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Anaheim, California, 92801
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Ann Arbor, Michigan, 48109
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Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28803
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Athens, Georgia, 30606
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Atlanta, Georgia, 30303
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Atlanta, Georgia, 30309
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Augusta, Georgia, 30909
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Aurora, Colorado, 80045
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Aventura, Florida, 33180
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21229
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Baltimore, Maryland, 21236
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Bangor, Maine, 04401
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Bay Pines, Florida, 33744
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Beverly Hills, California, 90211
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Biddeford, Maine, 04005
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Birmingham, Alabama, 35233
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Birmingham, Alabama, 35243
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02135
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Boynton Beach, Florida, 33472
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Brooklyn, New York, 11215
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Buffalo, New York, 14215
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Burbank, California, 91505
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Burlington, Vermont, 05401
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Butler, Pennsylvania, 16001
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Camp Hill, Pennsylvania, 17011
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Carmichael, California, 95608
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Carrollton, Texas, 75006
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Carrollton, Texas, 75010
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Cary, North Carolina, 27518
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Champaign, Illinois, 61820
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29401
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Charleston, South Carolina, 29407
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28203
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60612
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45220
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Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80909
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Columbia, Maryland, 21044
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Columbia, Missouri, 65201
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Columbia, Missouri, 65212
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Columbus, Georgia, 31904
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Columbus, Ohio, 43210
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Columbus, Ohio, 43214
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Cortlandt Manor, New York, 10567
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Crestview Hills, Kentucky, 41017
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Crystal River, Florida, 34429
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Dallas, Texas, 75216
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Dallas, Texas, 75231
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Dallas, Texas, 75246
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Dayton, Ohio, 45414
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Dayton, Ohio, 45419
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Daytona Beach, Florida, 32117
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Denison, Texas, 75020
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Denver, Colorado, 80204
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Denver, Colorado, 80218
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Des Moines, Iowa, 50314
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Detroit, Michigan, 48202
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Doral, Florida, 33126
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Durham, North Carolina, 27705
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Eatontown, New Jersey, 07724
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El Paso, Texas, 79935
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Erie, Pennsylvania, 16502
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Fairview Heights, Illinois, 62208
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Farmington, Utah, 84025
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Fort Mill, South Carolina, 29707
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Fort Payne, Alabama, 35967
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Fort Sam Houston, Texas, 78234
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Fort Worth, Texas, 76104
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Fresno, California, 93701
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Gainesville, Florida, 32608
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Galveston, Texas, 77555-0158
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Germantown, Tennessee, 38138
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Gilbert, Arizona, 85297
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Gonzales, Texas, 78629
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Grand Blanc, Michigan, 48439
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Green Bay, Wisconsin, 54301
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Greensboro, North Carolina, 27401
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Greenville, South Carolina, 29605
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Hagerstown, Maryland, 21740
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Hartford, Connecticut, 06102
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Haverhill, Massachusetts, 01830
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Hazel Crest, Illinois, 60429
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Hershey, Pennsylvania, 17033
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Hialeah, Florida, 33012
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Hialeah, Florida, 33013
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Hickory, North Carolina, 28601
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Honolulu, Hawaii, 96813
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Houston, Texas, 77025
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Houston, Texas, 77030
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Huntington, West Virginia, 25702
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Huntington Beach, California, 92648
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Huntsville, Alabama, 35801
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Huntsville, Texas, 77340
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Indianapolis, Indiana, 46227
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Inverness, Florida, 34452
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Iowa City, Iowa, 52242
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Jackson, Tennessee, 38301
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32209
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Jacksonville, Florida, 32216
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Jefferson City, Missouri, 65109
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Jersey Shore, Pennsylvania, 17740
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Johnson City, New York, 13790
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Jonesboro, Arkansas, 72401
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Kalamazoo, Michigan, 49008
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64108
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Kansas City, Missouri, 64128
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Kettering, Ohio, 45429
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Kingston, New York, 12401
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Knoxville, Tennessee, 37934
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Lake Charles, Louisiana, 70601
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Lancaster, Pennsylvania, 17603
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Las Vegas, Nevada, 89118
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Las Vegas, Nevada, 89128
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Laurelton, New York, 11413
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Lebanon, New Hampshire, 03756
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Leesburg, Virginia, 20176
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Lenoir, North Carolina, 28645
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Lexington, Kentucky, 40503
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Lincoln, Nebraska, 68506
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Little Rock, Arkansas, 72205
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Littleton, Colorado, 80120
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Loma Linda, California, 92357
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Long Beach, California, 90806
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Long Beach, California, 90822
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Los Alamitos, California, 90720
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Los Angeles, California, 90033
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Los Angeles, California, 90073
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40206
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Louisville, Kentucky, 40216
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Lubbock, Texas, 79430
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Lumberton, North Carolina, 28358
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Lynchburg, Virginia, 24501
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Madison, Wisconsin, 53705
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Madison, Wisconsin, 53713
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Madison, Wisconsin, 53792
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Manassas, Virginia, 20109
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Manitowoc, Wisconsin, 54220
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Marion, Ohio, 43302
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Maywood, Illinois, 60153
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McKinney, Texas, 75071
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Memphis, Tennessee, 38104
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Merrillville, Indiana, 46410
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Miami, Florida, 33032
Research Site
Miami, Florida, 33125
Research Site
Miami, Florida, 33126
Research Site
Miami, Florida, 33136
Research Site
Miami, Florida, 33144
Research Site
Miami, Florida, 33145
Research Site
Miami, Florida, 33147
Research Site
Miami, Florida, 33165
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Miami, Florida, 33166
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Miami, Florida, 33174
Research Site
Miami Beach, Florida, 33140
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Midland, Michigan, 48670
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Milwaukee, Wisconsin, 53201
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Milwaukee, Wisconsin, 53226
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Milwaukee, Wisconsin, 53295
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Mineola, New York, 11501
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Minneapolis, Minnesota, 55417
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Mission Viejo, California, 92691
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Mobile, Alabama, 36608
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Monroe, Louisiana, 71201
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Moorestown, New Jersey, 08057
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Mooresville, North Carolina, 28117
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Morgantown, West Virginia, 26506
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Morristown, New Jersey, 07960
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Muncie, Indiana, 47303
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Munster, Indiana, 46321
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Murray, Utah, 84107
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Naples, Florida, 34102
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Nashville, Tennessee, 37208
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Nashville, Tennessee, 37212
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Nashville, Tennessee, 37232
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New Orleans, Louisiana, 70112
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New York, New York, 10016
Research Site
New York, New York, 10025
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New York, New York, 10029
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Newark, Delaware, 19718
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Newark, New Jersey, 07112
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Newport Beach, California, 92663
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Norfolk, Virginia, 23510
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North Las Vegas, Nevada, 89086
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Northridge, California, 91325
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Oak Lawn, Illinois, 60453
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Oak Ridge, Tennessee, 37830
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Ocala, Florida, 34471
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Odessa, Texas, 79761
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Oklahoma City, Oklahoma, 73135
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Omaha, Nebraska, 68198
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Overland Park, Kansas, 66209
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Palm Harbor, Florida, 34684
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Pawtucket, Rhode Island, 02860
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Pembroke Pines, Florida, 33028
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Peoria, Illinois, 61606
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Philadelphia, Pennsylvania, 19102
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19114
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Philadelphia, Pennsylvania, 19141
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Phoenix, Arizona, 85032
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15212
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Pittsburgh, Pennsylvania, 15213
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Plano, Texas, 75024
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Port Gibson, Mississippi, 39150
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Portland, Maine, 04101
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Powell, Tennessee, 37849
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Prince Frederick, Maryland, 20678
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Providence, Rhode Island, 02906
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Providence, Rhode Island, 02908
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Puyallup, Washington, 98372
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Rapid City, South Dakota, 57701
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Redondo Beach, California, 90277
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Reno, Nevada, 89502
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Richmond, Indiana, 47374
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Richmond, Virginia, 23226
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Richmond, Virginia, 23249
Research Site
Richmond, Virginia, 23298
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Ridgewood, New Jersey, 07450
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Riverside, California, 92506
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Rochester, New York, 14621
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Rock Hill, South Carolina, 29732
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Roslyn, New York, 11576
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Royal Oak, Michigan, 48073
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Sacramento, California, 95819
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Saginaw, Michigan, 48601
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Saint Paul, Minnesota, 55101
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Salisbury, Maryland, 21804
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Salt Lake City, Utah, 84132
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San Antonio, Texas, 78229
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San Francisco, California, 94115
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San Pedro, California, 90732
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Sandusky, Ohio, 44870
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Santa Ana, California, 92704
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Santa Rosa, California, 95405
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Sarasota, Florida, 34232
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Saratoga Springs, New York, 12866
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Sayre, Pennsylvania, 18840
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Scarborough, Maine, 04074
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Scottsboro, Alabama, 35768
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Seattle, Washington, 98122
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Shreveport, Louisiana, 71103
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Shreveport, Louisiana, 71105
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Smyrna, Georgia, 30082
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Somerset, New Jersey, 08873
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Spokane, Washington, 99204
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Springfield, Missouri, 65807
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St Louis, Missouri, 63110
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Stamford, Connecticut, 06905
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Stanford, California, 94305
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Stockton, California, 95204
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Stony Brook, New York, 11794
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Tabor City, North Carolina, 28463
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Tampa, Florida, 33613
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The Bronx, New York, 10467
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Tomball, Texas, 77375
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Torrance, California, 90502
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Torrance, California, 90503
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Tucson, Arizona, 85710
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Tucson, Arizona, 85724
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74104
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Tulsa, Oklahoma, 74127
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Tupelo, Mississippi, 38801
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Tuscumbia, Alabama, 35674
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Tustin, California, 92780
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Valhalla, New York, 10595
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Valparaiso, Indiana, 46383
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Ventura, California, 93003
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Virginia Beach, Virginia, 23454
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Voorhees Township, New Jersey, 08043
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Warwick, Rhode Island, 02886
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Washington D.C., District of Columbia, 20010
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Washington D.C., District of Columbia, 20037
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Washington D.C., District of Columbia, 20422
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Waterbury, Connecticut, 06708
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Waukesha, Wisconsin, 53188
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West Haven, Connecticut, 06516
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West Monroe, Louisiana, 71291
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Wheat Ridge, Colorado, 80033
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White River Junction, Vermont, 05009

Other trials in United States

Japan96 sites

Research Site
Ageo-shi, Saitama, 362-8588
Research Site
Akishima-shi, Tokyo, 196-0003
Research Site
Amagasaki-shi, Hyōgo, 660-8550
Research Site
Asahi-shi, Chiba, 289-2511
Research Site
Bunkyo-ku, Tokyo, 113-8519
Research Site
Bunkyo-ku, Tokyo, 113-8603
Research Site
Chiba, Chiba, 260-8606
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Chikushino-shi, Fukuoka, 818-8516
Research Site
Chuo-ku, Tokyo, 104-8560
Research Site
Fukuoka, Fukuoka, 810-0001
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Fukuoka, Fukuoka, 810-8539
Research Site
Fukuoka, Fukuoka, 811-0213
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Fukuoka, Fukuoka, 812-0033
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Fukuoka, Fukuoka, 814-0180
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Fukuoka, Fukuoka, 815-8555
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Fukuoka, Fukuoka, 815-8588
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Fukushima, Fukushima, 960-1295
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Fukushima, Fukushima, 960-8251
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Fukushima, Fukushima, 960-8530
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Fukuyama-shi, Hiroshima, 721-8511
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Funabashi-shi, Chiba, 273-8588
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Fussa-shi, Tokyo, 197-8511
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Hachioji-shi, Tokyo, 192-0918
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Hakodate-shi, Hokkaido, 041-8512
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Hayama, Kanagawa, 240-0116
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Higashiibaraki-gun, Ibaraki, 311-3193
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Higashiosaka-shi, Osaka, 579-8056
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Himeji-shi, Hyōgo, 670-0981
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Hiroshima, Hiroshima, 734-8551
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Ichinomiya-shi, Aichi-ken, 491-8551
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Imabari, Ehime, 794-0006
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Kahoku-gun, Ishikawa-ken, 920-0293
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Kanazawa, Ishikawa-ken, 920-8650
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Kashihara-shi, Nara, 634-8522
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Kasuya-gun, Fukuoka, 811-2316
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Kawanishi-shi, Hyōgo, 666-0125
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Kawasaki-shi, Kanagawa, 210-0852
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Kawasaki-shi, Kanagawa, 211-8533
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Kawasaki-shi, Kanagawa, 216-8511
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Kitakyushu-shi, Fukuoka, 802-0077
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Kitakyushu-shi, Fukuoka, 802-8555
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Kitakyushu-shi, Fukuoka, 805-8508
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Kodaira-shi, Tokyo, 187-8510
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Koga-shi, Fukuoka, 811-3195
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Koshigaya-shi, Saitama, 343-8577
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Kumamoto, Kumamoto, 861-4193
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Kure-shi, Hiroshima, 737-0023
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Kurume-shi, Fukuoka, 830-8577
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Kurume-shi, Fukuoka, 839-0863
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Kusatsu-shi, Shiga, 525-8585
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Maebashi, Gunma, 371-8511
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Matsubara-shi, Osaka, 580-0032
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Matsuyama, Ehime, 790-0067
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Meguro-ku, Tokyo, 152-8902
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Minato-ku, Tokyo, 108-8642
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Morioka, Iwate, 020-0066
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Nagakute-shi, Aichi-ken, 480-1195
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Nagano, Nagano, 381-8551
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Nagoya, Aichi-ken, 454-8509
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Nagoya, Aichi-ken, 466-8560
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Naha, Okinawa, 902-8511
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Nankoku-shi, Kochi, 783-8505
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Nishinomiya-shi, Hyōgo, 663-8501
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Odawara-shi, Kanagawa, 250-8558
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Ogaki-shi, Gifu, 503-8502
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Ōita, Oita Prefecture, 870-0192
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Okayama, Okayama-ken, 700-8558
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Onga-gun, Fukuoka, 807-0051
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Osaka, Osaka, 530-0001
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Osaka, Osaka, 533-0024
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Osaka, Osaka, 540-0006
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Osaka, Osaka, 556-0017
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Osaka, Osaka, 559-0012
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Saga, Saga-ken, 849-8501
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Sagamihara-shi, Kanagawa, 252-0392
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Sagamihara-shi, Kanagawa, 252-5188
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Sapporo, Hokkaido, 063-0005
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Sendai, Miyagi, 980-8574
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Seto-shi, Aichi-ken, 489-8642
Research Site
Shimajiri-gun, Okinawa, 901-0493
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Shinagawa-ku, Tokyo, 140-8522
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Shinjuku-ku, Tokyo, 162-8655
Research Site
Suita-shi, Osaka, 565-0871
Research Site
Sunto-gun, Shizuoka, 411-8611
Research Site
tabashi City, Tokyo, 173-8610
Research Site
Takamatsu, Kagawa-ken, 760-8557
Research Site
Takarazuka-shi, Hyōgo, 665-0873
Research Site
Takasaki-shi, Gunma, 370-0829
Research Site
Toyama, Toyama, 939-8511
Research Site
Urasoe-shi, Okinawa, 901-2132
Research Site
Urayasu-shi, Chiba, 279-0021
Research Site
Ureshino-shi, Saga-ken, 843-0301
Research Site
Wako-shi, Saitama, 351-0102
Research Site
Yokohama, Kanagawa, 227-8501
Research Site
Yokohama, Kanagawa, 231-8682
Research Site
Yokohama, Kanagawa, 247-8581

Other trials in Japan

China38 sites

Research Site
Beijing, Beijing Municipality, 100043
Research Site
Beijing, Beijing Municipality, 100191
Research Site
Beijing, 100020
Research Site
Beijing, 100037
Research Site
Changchun, Jilin, 130021
Research Site
Changchun, Jilin, 130033
Research Site
Guangzhou, Guangdong, 510080
Research Site
Guangzhou, Guangdong, 511400
Research Site
Haikou, Hainan, 570102
Research Site
Hangzhou, Zhejiang, 310000
Research Site
Harbin, Heilongjiang, 150001
Research Site
Hengyang, Hunan, 421001
Research Site
Heze, Shandong, 274031
Research Site
Hohhot, Inner Mongolia, 010017
Research Site
Jinan, Shandong, 250012
Research Site
Jining, Shandong, 272009
Research Site
Linhai, Zhejiang, 317000
Research Site
Luoyang, Henan, 471000
Research Site
Luoyang, Henan, 471009
Research Site
Nanjing, Jiangsu, 211100
Research Site
Ningbo, Zhejiang, 315010
Research Site
Qingdao, Shandong, 266003
Research Site
Shanghai, 200080
Research Site
Shenyang, Liaoning, 110000
Research Site
Shenyang, Liaoning, 110004
Research Site
Shenyang, Liaoning, 110016
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Suzhou, Jiangsu, 215000
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Taiyuan, Shanxi, 030001
Research Site
Taiyuan, Shanxi, 030012
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Tianjin, Tianjin Municipality, 300052
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Ürümqi, Xinjiang, 830054
Research Site
Wuxi, Jiangsu, 214023
Research Site
Xi'an, Shaanxi, 710061
Research Site
Xiangtan, Hunan, 411100
Research Site
Xinxiang, Henan, 453000
Research Site
Xuzhou, Jiangsu, 221006
Research Site
Yuncheng, Shanxi, 044000
Research Site
Zhengzhou, Henan, 450052

Other trials in China

Russia38 sites

Research Site
Arkhangelsk, 163001
Research Site
Barnaul, 656038
Research Site
Ivanovo, 153012
Research Site
Izhevsk, 426063
Research Site
Kemerovo, 650002
Research Site
Kemerovo, 650099
Research Site
Kirov, 610014
Research Site
Korolyov, 141060
Research Site
Krasnodar, 350086
Research Site
Lomonosov, 198412
Research Site
Moscow, 101990
Research Site
Moscow, 117292
Research Site
Moscow, 119192
Research Site
Moscow, 121552
Research Site
Moscow, 123182
Research Site
Moscow, 127299
Research Site
Moscow, 129090
Research Site
Moscow, 129327
Research Site
Nizhny Novgorod, 603076
Research Site
Nizhny Novgorod, 603126
Research Site
Novosibirsk, 630008
Research Site
Novosibirsk, 630087
Research Site
Novosibirsk, 630089
Research Site
Omsk, 644018
Research Site
Saint Petersburg, 191015
Research Site
Saint Petersburg, 192242
Research Site
Saint Petersburg, 194156
Research Site
Saint Petersburg, 195112
Research Site
Saint Petersburg, 196601
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 198205
Research Site
Saint Petersburg, 199106
Research Site
Saratov, 410054
Research Site
Tomsk, 634012
Research Site
Village Novoseltsy, 214016
Research Site
Vladimir, 600020
Research Site
Yaroslavl, 150030
Research Site
Yekaterinburg, 620102

Other trials in Russia

Argentina37 sites

Research Site
Bahía Blanca, Buenos Aires, B8000FTD
Research Site
Buenos Aires, 1425
Research Site
CABA, Buenos Aires, C1119ACN
Research Site
CABA, Buenos Aires, C1406BOA
Research Site
CABA, Buenos Aires, C1407GTN
Research Site
CABA, Buenos Aires, C1428ART
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1209
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP
Research Site
Córdoba, Córdoba Province, 5000
Research Site
Córdoba, Córdoba Province, X5004BAL
Research Site
Córdoba, Córdoba Province, X5006IKK
Research Site
Córdoba, Córdoba Province, X5016KEH
Research Site
Córdoba, 5000
Research Site
Córdoba, X5003DCE
Research Site
Córdoba, X5021FPQ
Research Site
Coronel Suárez, Buenos Aires, B7540GHD
Research Site
Corrientes, 3400
Research Site
Corrientes, W3400AMZ
Research Site
Mar del Plata, Buenos Aires, B7600FZN
Research Site
Merlo, Buenos Aires, B1722COV
Research Site
Quilmes, Buenos Aires, 1878
Research Site
Quilmes, Buenos Aires, B1878DVB
Research Site
Ramos Meija, Buenos Aires, B1704ETD
Research Site
Rosario, Santa Fe Province, 2000
Research Site
Rosario, Santa Fe Province, S2000BIF
Research Site
Salta, A4406BPF
Research Site
San Fernando, Buenos Aires, B1646EBJ
Research Site
San Isidro, Buenos Aires, B1642DSF
Research Site
San Martín, Buenos Aires, B1650CSQ
Research Site
San Miguel de Tucumán, Tucumán Province, 4000
Research Site
San Miguel de Tucumán, Tucumán Province, T4000JCV
Research Site
San Nicolás de los Arroyos, Buenos Aires, B2900DPA
Research Site
Santa Fe, S3000FWO
Research Site
Santa Rosa, La Pampa Province, 6300
Research Site
Venado Tuerto, Santa Fe Province, 2600
Research Site
Villa María, Córdoba Province, X5900JKA

Other trials in Argentina

United Kingdom34 sites

Research Site
Ayr, KA6 6DX
Research Site
Basingstoke, RG24 9NA
Research Site
Belfast, BT16 1RH
Research Site
Blackpool, FY3 8NR
Research Site
Corby, NN17 2UR
Research Site
Cottingham, HU16 5JQ
Research Site
Dudley, DY1 2HQ
Research Site
Dundee, DD1 9SY
Research Site
Exeter, EX2 5DW
Research Site
Gillingham, ME7 5NY
Research Site
Glasgow, G75 8RG
Research Site
Harlow, CM20 1QX
Research Site
High Wycombe, HP11 2TT
Research Site
London, N18 1QX
Research Site
London, SW3 6NP
Research Site
London, W12 0HS
Research Site
Merthyr Tydfil, CF47 9DT
Research Site
Newport, PO30 5TG
Research Site
Northampton, NN1 5BD
Research Site
Northwood, HA6 2RN
Research Site
Norwich, NR4 7UY
Research Site
Peterborough, PE3 9GZ
Research Site
Portsmouth, PO6 3LY
Research Site
Romford, RM1 3PJ
Research Site
Sheffield, S5 7AU
Research Site
Shipley, BD18 3SA
Research Site
Sidcup, DA14 6LT
Research Site
Solihull, B91 2JL
Research Site
Stevenage, SG1 4AB
Research Site
Sunderland, SR4 7TP
Research Site
Swindon, SN3 6BB
Research Site
Taunton, TA1 5DA
Research Site
Torquay, TQ2 7AA
Research Site
Worcester, WR5 1DD

Other trials in United Kingdom

Poland32 sites

Research Site
Bialystok, 15-276
Research Site
Bytom, 41-902
Research Site
Gdansk, 80-262
Research Site
Gdynia, 81-157
Research Site
Gdynia, 81-423
Research Site
Giżycko, 11-500
Research Site
Kazimierza Wielka, 28-500
Research Site
Kielce, 25-736
Research Site
Kłodzko, 57-300
Research Site
Krakow, 30-069
Research Site
Krakow, 30-082
Research Site
Krakow, 31-202
Research Site
Lodz, 90-549
Research Site
Lodz, 91-347
Research Site
Lodz, 92-213
Research Site
Lublin, 20-078
Research Site
Lublin, 20-857
Research Site
Miechów, 32-200
Research Site
Oława, 55-200
Research Site
Piotrkow Trybunalski, 97-300
Research Site
Poznan, 61-848
Research Site
Ruda Śląska, 41-709
Research Site
Skierniewice, 96-100
Research Site
Stalowa Wola, 37-450
Research Site
Świdnik, 21-040
Research Site
Tarnów, 33-100
Research Site
Torun, 87-100
Research Site
Warsaw, 02-097
Research Site
Warsaw, 04-628
Research Site
Włocławek, 87-800
Research Site
Wroclaw, 51-124
Research Site
Zabrze, 41-800

Other trials in Poland

Brazil31 sites

Research Site
Aracaju, Sergipe, 49055-530
Research Site
Belo Horizonte, Minas Gerais, 30150-240
Research Site
Belo Horizonte, Minas Gerais, 31110-580
Research Site
Brasília, Federal District, 70673-900
Research Site
Campinas, São Paulo, 13010-001
Research Site
Campinas, São Paulo, 13060-080
Research Site
Campinas, São Paulo, 13083-888
Research Site
Canoas, Rio Grande do Sul, 92425-900
Research Site
Curitiba, Paraná, 80045-170
Research Site
Curitiba, Paraná, 80230-130
Research Site
Curitiba, Paraná, 80730-150
Research Site
Goiânia, Goiás, 74223-130
Research Site
Goiânia, Goiás, 74605-020
Research Site
Londrina, Paraná, 86038-350
Research Site
Marília, São Paulo, 17515-000
Research Site
Natal, Rio Grande do Norte, 59020-035
Research Site
Passo Fundo, Rio Grande do Sul, 99010-080
Research Site
Porto Alegre, Rio Grande do Sul, 90020-090
Research Site
Porto Alegre, Rio Grande do Sul, 90035-903
Research Site
Porto Alegre, Rio Grande do Sul, 90840-440
Research Site
Porto Alegre, Rio Grande do Sul, 91350-200
Research Site
Ribeirão Preto, São Paulo, 14048-900
Research Site
Rio de Janeiro, 22271-100
Research Site
São José do Rio Preto, São Paulo, 15015-770
Research Site
São José do Rio Preto, São Paulo, 15090-000
Research Site
São Paulo, São Paulo, 01317 002
Research Site
São Paulo, São Paulo, 04005-000
Research Site
São Paulo, São Paulo, 08270-120
Research Site
São Paulo, 04012-909
Research Site
São Paulo, 05403-000
Research Site
Uberlândia, Minas Gerais, 38411-186

Other trials in Brazil

Canada31 sites

Research Site
Brampton, Ontario, L6W 2X7
Research Site
Brampton, Ontario, L6Z 4N5
Research Site
Cambridge, Ontario, N1R 6V6
Research Site
Chicoutimi, Quebec, G7H 7K9
Research Site
Edmonton, Alberta, T6G 2B7
Research Site
Edmonton, Alberta, T6K 4C1
Research Site
Greater Sudbury, Ontario, P3E 5M4
Research Site
Greenfield Park, Quebec, J4V 2G8
Research Site
Halifax, Nova Scotia, B3H 3A7
Research Site
Kelowna, British Columbia, V1Y 1V6
Research Site
Laval, Quebec, H7M 3L9
Research Site
London, Ontario, N6A 5A5
Research Site
Moncton, New Brunswick, E1G 1A7
Research Site
Montreal, Quebec, H1T 1C8
Research Site
Montreal, Quebec, H1T 3Y7
Research Site
Montreal, Quebec, H3G 1A4
Research Site
Montreal, Quebec, H4A 3J1
Research Site
New Westminster, British Columbia, V3L 3W4
Research Site
North Vancouver, British Columbia, V7M 2H4
Research Site
Oshawa, Ontario, L1J 2J9
Research Site
Ottawa, Ontario, K1Y 4W7
Research Site
Peterborough, Ontario, K9J 0B2
Research Site
Québec, Quebec, G1V 4G5
Research Site
Saint-Jean-sur-Richelieu, Quebec, J3A 1J2
Research Site
Saint-Jérôme, Quebec, J7Z 5T3
Research Site
Scarborough Village, Ontario, M1P 2V5
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Terrebonne, Quebec, J6V 2H2
Research Site
Toronto, Ontario, M5B 1W8
Research Site
Waterloo, Ontario, N2T 0C1
Research Site
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

Czechia31 sites

Research Site
Beroun, 266 01
Research Site
Brandýs nad Labem, 250 01
Research Site
Brno, 602 00
Research Site
Brno, 625 00
Research Site
Brno, 636 00
Research Site
Brno, 656 91
Research Site
Frýdek-Místek, 738 01
Research Site
Havlíčkův Brod, 580 22
Research Site
Hradec Králové, 500 05
Research Site
Jihlava, 586 33
Research Site
Karlovy Vary, 360 01
Research Site
Kladno, 272 59
Research Site
Klatovy IV, 339 01
Research Site
Kolin III, 280 02
Research Site
Liberec, 460 63
Research Site
Louny, 440 01
Research Site
Mariánské Lázně, 353 01
Research Site
Mohelnice, 789 85
Research Site
Opava, 746 01
Research Site
Ostrava, 728 80
Research Site
Polička, 572 01
Research Site
Prague, 100 34
Research Site
Prague, 110 00
Research Site
Prague, 128 08
Research Site
Praha 5 - Smichov, 150 00
Research Site
Pribram VIII, 261 01
Research Site
Svitavy, 568 25
Research Site
Teplice, 415 01
Research Site
Uherské Hradiště, 686 01
Research Site
Zlín, 762 75
Research Site
Znojmo, 669 02

Other trials in Czechia

France29 sites

Research Site
Béziers, 34525
Research Site
Caen, 14033
Research Site
Chambray-lès-Tours, 37170
Research Site
Corbeil-Essonnes, 91100
Research Site
Créteil, 94010
Research Site
Dijon, 21000
Research Site
Grenoble, 38043
Research Site
Le Chesnay, 78157
Research Site
Lille, 59000
Research Site
Lille, 59037
Research Site
Limoges, 87042
Research Site
Lyon, 69384
Research Site
Montauban, 82017
Research Site
Montpellier, 34295
Research Site
Nantes, 44093
Research Site
Nantes, 44277
Research Site
Nîmes, 30029
Research Site
Paris, 75010
Research Site
Paris, 75014
Research Site
Paris, 75018
Research Site
Paris, 75651
Research Site
Pessac, 33604
Research Site
Poitiers, 86000
Research Site
Rennes, 35033
Research Site
Saint-Denis, 93200
Research Site
Toulon, 83056
Research Site
Toulouse, 31059
Research Site
Tourcoing, 59208
Research Site
Valenciennes, 59300

Other trials in France

Italy29 sites

Research Site
Ariccia, 00072
Research Site
Arzignano, 36071
Research Site
Bergamo, 24127
Research Site
Bologna, 40139
Research Site
Brescia, 25123
Research Site
Cagliari, 09134
Research Site
Catania, 95123
Research Site
Catanzaro, 88100
Research Site
Cona FE, 44124
Research Site
Cuneo, 12100
Research Site
Foggia, 71100
Research Site
Milan, 20132
Research Site
Milan, 20138
Research Site
Milan, 20162
Research Site
Monza, 20900
Research Site
Monza (MB), 20900
Research Site
Naples, 80131
Research Site
Palermo, 90146
Research Site
Pavia, 27100
Research Site
Perugia, 06156
Research Site
Piacenza, 29121
Research Site
Rimini, 47923
Research Site
Roma, 00163
Research Site
Rozzano MI, 20089
Research Site
Seriate, 24068
Research Site
Siena, 53100
Research Site
Torrette Di Ancona, 60126
Research Site
Trieste, 34149
Research Site
Vimercate MB, 20871

Other trials in Italy

Hungary24 sites

Research Site
Balatonfüred, 8230
Research Site
Békéscsaba, 5600
Research Site
Berettyóújfalu, 4100
Research Site
Budapest, 1023
Research Site
Budapest, 1037
Research Site
Budapest, 1085
Research Site
Budapest, 1096
Research Site
Budapest, 1122
Research Site
Budapest, 1125
Research Site
Budapest, 1134
Research Site
Cegléd, 2700
Research Site
Dunaújváros, 2400
Research Site
Gyöngyös, 3200
Research Site
Gyula, 5700
Research Site
Kaposvár, 7400
Research Site
Komárom, 2921
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7624
Research Site
Sopron, 9400
Research Site
Szeged, 6725
Research Site
Szekszárd, 7100
Research Site
Szentes, 6600
Research Site
Szolnok, 5004
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Germany22 sites

Research Site
Bad Neuheim, 61231
Research Site
Berlin, 13353
Research Site
Cologne, 50937
Research Site
Dortmund, 44137
Research Site
Düsseldorf, 40225
Research Site
Erfurt, 99089
Research Site
Erfurt, 99097
Research Site
Essen, 45147
Research Site
Frankfurt am Main, 65929
Research Site
Freiburg im Breisgau, 79106
Research Site
Göttingen, 37075
Research Site
Greifswald, 17475
Research Site
Haßloch, 67454
Research Site
Heidelberg, 69120
Research Site
Homburg, 66421
Research Site
Langen, 63225
Research Site
Leipzig, 04289
Research Site
Ludwigshafen, 67063
Research Site
Mainz, 55131
Research Site
Markleeberg, 04416
Research Site
Witten, 58455
Research Site
Würzburg, 97078

Other trials in Germany

Spain22 sites

Research Site
A Coruña, Galicia, 15006
Research Site
Alicante, Valencia, 03010
Research Site
Barcelona, Catalonia, 08041
Research Site
Córdoba, Andalusia, 14004
Research Site
El Palmar, Murcia, 30120
Research Site
Granada, Andalusia, 18014
Research Site
Madrid, 28007
Research Site
Madrid, 28040
Research Site
Madrid, 28041
Research Site
Majadahonda, Madrid, 28222
Research Site
Málaga, Andalusia, 29010
Research Site
Oviedo, Principality of Asturias, 33011
Research Site
San Cristóbal de La Laguna, Canary Islands, 38320
Research Site
Santander, Cantabria, 39008
Research Site
Santiago de Compostela, Galicia, 15706
Research Site
Seville, Andalusia, 41009
Research Site
Úbeda, Andalusia, 23400
Research Site
Valencia, Valencia, 46010
Research Site
Valencia, Valencia, 46026
Research Site
Valladolid, Castille and León, 47005
Research Site
Vigo, Galicia, 36312
Research Site
Zaragoza, Aragon, 50009

Other trials in Spain

Ukraine20 sites

Research Site
Dnipropetrovsk, 49060
Research Site
Ivano-Frankivsk, 76018
Research Site
Kharkiv, 61002
Research Site
Kharkiv, 61018
Research Site
Kharkiv, 61039
Research Site
Kharkiv, 61106
Research Site
Kharkiv, 61176
Research Site
Kyiv, 01601
Research Site
Kyiv, 02091
Research Site
Kyiv, 02232
Research Site
Kyiv, 02660
Research Site
Kyiv, 03151
Research Site
Kyiv, 03680
Research Site
Lutsk, 43024
Research Site
Uzhhorod, 88014
Research Site
Vinnytsia, 21001
Research Site
Vinnytsia, 21018
Research Site
Vinnytsia, 21029
Research Site
Zaporizhzhya, 69035
Research Site
Zaporizhzhya, 69600

Other trials in Ukraine

Netherlands19 sites

Research Site
's-Hertogenbosch, 5223 GZ
Research Site
Almelo, 7609 PP
Research Site
Arnhem, 6815 AD
Research Site
Breda, 4818 CK
Research Site
Capelle aan den IJssel, 2906 ZC
Research Site
Den Helder, 1782 GZ
Research Site
Deventer, 7416 SE
Research Site
Doetinchem, 7009 BL
Research Site
Emmen, 7824 AA
Research Site
Goes, 4462 RA
Research Site
Groningen, 9713 GZ
Research Site
Groningen, 9728 NT
Research Site
Leiderdorp, 2353 GA
Research Site
Nijmegen, 6532 SZ
Research Site
Tiel, 4002 WP
Research Site
Tilburg, 5022 GC
Research Site
Tilburg, 5042 AD
Research Site
Uden, 5406 PT
Research Site
Zwolle, 8025 AB

Other trials in Netherlands

Turkey (Türkiye)19 sites

Research Site
Adana, 01330
Research Site
Afyonkarahisar, 03218
Research Site
Ankara, 06100
Research Site
Ankara, 06490
Research Site
Çorum, 19040
Research Site
Eskişehir, 26040
Research Site
Istanbul, 34096
Research Site
Istanbul, 34098
Research Site
Istanbul, 34200
Research Site
Istanbul, 34865
Research Site
Izmir, 35100
Research Site
Izmir, 35340
Research Site
Kirikkale, 71100
Research Site
Kocaeli, 41380
Research Site
Konya, 42080
Research Site
Mersin, 33343
Research Site
Sakarya, 54100
Research Site
Sivas, 58140
Research Site
Van, 65100

Other trials in Turkey (Türkiye)

Australia17 sites

Research Site
Ashford, South Australia, 5035
Research Site
Bedford Park, South Australia, 5042
Research Site
Bundoora, Victoria, 3083
Research Site
Chermside, Queensland, 4032
Research Site
Concord, New South Wales, 2139
Research Site
Darlinghurst, New South Wales, 2010
Research Site
Frankston, Victoria, 3199
Research Site
Fullarton, South Australia, 5063
Research Site
Garran, Australian Capital Territory, 2605
Research Site
Geelong, Victoria, 3220
Research Site
Herston, Queensland, 4029
Research Site
Liverpool, New South Wales, 2170
Research Site
Murdoch, Western Australia, 6150
Research Site
New Lambton Heights, New South Wales, 2305
Research Site
Richmond, Victoria, 3121
Research Site
Woodville South, South Australia, 5011
Research Site
Woolloongabba, Queensland, 4102

Other trials in Australia

Mexico16 sites

Research Site
Aguascalientes, 20230
Research Site
Culiacán, Sinaloa, 80230
Research Site
Guadalajara, Jalisco, 44280
Research Site
Guadalajara, Jalisco, 44340
Research Site
Guadalajara, Jalisco, 44670
Research Site
Mexico City, Mexico City, 06700
Research Site
Mexico City, Mexico City, 11650
Research Site
Mexico City, Mexico City, 14080
Research Site
Monterrey, Nuevo León, 64060
Research Site
Monterrey, Nuevo León, 64460
Research Site
Pachuca, Hidalgo, 42070
Research Site
Querétaro City, Querétaro, 76000
Research Site
San Luis Potosí City, San Luis Potosí, 78200
Research Site
Torreón, Coahuila, 27000
Research Site
Xalapa, Veracruz, 91193
Research Site
Zapopan, Jalisco, 45030

Other trials in Mexico

Colombia14 sites

Research Site
Armenia, Quindío Department, 630004
Research Site
Barranquilla, Atlántico, 080020
Research Site
Barranquilla, Atlántico
Research Site
Bogota D.C.
Research Site
Bucaramanga, Santander Department, 680008
Research Site
Bucaramanga, Santander Department, 681004
Research Site
Cali, Valle del Cauca Department, 760032
Research Site
Cali, Valle del Cauca Department, 760042
Research Site
Cartagena, Departamento de Bolívar, 130010
Research Site
Manizales, Caldas Department
Research Site
Medellín, Antioquia, 05001000
Research Site
Medellín, Antioquia, 050012
Research Site
Medellín, Antioquia, 050021
Research Site
Medellín, Antioquia, 050034

Other trials in Colombia

Romania14 sites

Research Site
Bucharest, 014461
Research Site
Bucharest, 021659
Research Site
Bucharest, 022322
Research Site
Bucharest, 050098
Research Site
Cluj-Napoca, 400347
Research Site
Craiova, 200383
Research Site
Craiova, 200642
Research Site
Iași, 700661
Research Site
Iași, 700732
Research Site
Oradea, 410169
Research Site
Piteşti, 110438
Research Site
Targoviste, 130095
Research Site
Târgu Mureş, 540143
Research Site
Timișoara, 300079

Other trials in Romania

Slovakia14 sites

Research Site
Banská Bystrica, 974 01
Research Site
Bardejov, 085 01
Research Site
Bratislava, 811 08
Research Site
Bratislava, 826 06
Research Site
Bratislava, 833 48
Research Site
Brezno, 977 42
Research Site
Košice, 040 01
Research Site
Levice, 934 01
Research Site
Nitra, 950 01
Research Site
Prešov, 080 01
Research Site
Rimavská Sobota, 979 01
Research Site
Snina, 069 01
Research Site
Svidník, 089 01
Research Site
Trnava, 917 75

Other trials in Slovakia

Chile13 sites

Research Site
Osorno, 5311092
Research Site
San Miguel, Santiago Metropolitan, 8900085
Research Site
Santiago, 7500739
Research Site
Santiago, 8207257
Research Site
Santiago, 8330034
Research Site
Santiago, 8350595
Research Site
Santiago, 8880300
Research Site
Santiago, 8910259
Research Site
Santiago
Research Site
Talcahuano, Concepción, 4270918
Research Site
Temuco, Cautín, 4781156
Research Site
Temuco, Cautín, 4813299
Research Site
Viña del Mar, Valparaiso

Other trials in Chile

Greece11 sites

Research Site
Alexandroupoli, 68100
Research Site
Athens, 11527
Research Site
Athens, 14233
Research Site
Athens, 16673
Research Site
Chaidari, Athens, 12462
Research Site
Chalcis, 34100
Research Site
Heraklion, 71110
Research Site
Ioannina, 45500
Research Site
Larissa, 41110
Research Site
Thessaloniki, 54636
Research Site
Thessaloniki, 56403

Other trials in Greece

Austria9 sites

Research Site
Feldkirch, 6807
Research Site
Graz, 8036
Research Site
Innsbruck, 6020
Research Site
Linz, 4010
Research Site
Linz, 4020
Research Site
Sankt Pölten, 3100
Research Site
Vienna, 1090
Research Site
Vienna, 1160
Research Site
Villach, 9500

Other trials in Austria

Denmark9 sites

Research Site
Aalborg, 9000
Research Site
Aarhus N, 8200
Research Site
Esbjerg, 6700
Research Site
Glostrup Municipality, 2600
Research Site
Hellerup, 2900
Research Site
Hillerød, 3400
Research Site
Køge, 4600
Research Site
Odense, 5000
Research Site
Svendborg, 5700

Other trials in Denmark

South Africa9 sites

Research Site
Bloemfontein, Free State, 9301
Research Site
Durban, KwaZulu-Natal, 4001
Research Site
Parktown, Gauteng, 2193
Research Site
Parow, Western Cape, 7505
Research Site
Somerset West, Western Cape, 7130
Research Site
Soweto, Gauteng, 2013
Research Site
Sunninghill, Gauteng, 2157
Research Site
Umhlanga, KwaZulu-Natal, 4320
Research Site
Worcester, Western Cape, 6850

Other trials in South Africa

Bulgaria8 sites

Research Site
Haskovo, 6300
Research Site
Pleven, 5800
Research Site
Sandanski, 2800
Research Site
Sofia, 1202
Research Site
Sofia, 1233
Research Site
Sofia, 1407
Research Site
Sofia, 1527
Research Site
Sofia, 1750

Other trials in Bulgaria

Portugal8 sites

Research Site
Aveiro, 3814-501
Research Site
Coimbra, 3000-075
Research Site
Covilha, 6200-251
Research Site
Guimarães, 4835-044
Research Site
Lisbon, 1449-005
Research Site
Lisbon, 1500-650
Research Site
Lisbon, 1649-035
Research Site
Setúbal, 2910-446

Other trials in Portugal

Belgium7 sites

Research Site
Aalst, 9300
Research Site
Genk, 3600
Research Site
Ghent, 9000
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Lodelinsart, 6042
Research Site
Roeselare, 8800

Other trials in Belgium

Sweden7 sites

Research Site
Falun, 791 82
Research Site
Jönköping, 553 05
Research Site
Lidköping, 531 85
Research Site
Linköping, 581 85
Research Site
Lund, 222 21
Research Site
Örebro, 701 85
Research Site
Skellefteå, 931 86

Other trials in Sweden

Switzerland7 sites

Research Site
Basel, 4031
Research Site
Bern, 3010
Research Site
Fribourg, 1708
Research Site
Geneva, 1211
Research Site
Lausanne, 1011
Research Site
Lugano, 6900
Research Site
Zurich, 8032

Other trials in Switzerland

Lithuania4 sites

Research Site
Kaunas, 50009
Research Site
Klaipėda, 92288
Research Site
Vilnius, 08661
Research Site
Vilnius, 08861

Other trials in Lithuania

New Zealand3 sites

Research Site
Christchurch, 8011
Research Site
Papatoetoe, Auckland, 2025
Research Site
Takapuna, Auckland, 0620

Other trials in New Zealand

Puerto Rico1 site

Research Site
San Juan, 00926-2832

Other trials in Puerto Rico

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)

Read the detailed description

This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021 and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics, Cytokinetics is now listed as the sponsor.

Conditions: Heart Failure
Being tested: Omecamtiv Mecarbil, Placebo, Standard of Care
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Omecamtiv MecarbilDrug
Also called AMG 423
Omecamtiv mecarbil tablets for oral administration
PlaceboDrug
Matching placebo tablets
Standard of CareDrug
Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.

Study groups in NCT02929329
Study group	Role	What they receive
Omecamtiv Mecarbil	Experimental	Participants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations < 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and < 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and < 1000 ng/mL maintained a 25 mg BID dosing regimen. Receives: Drug: Omecamtiv Mecarbil; Drug: Standard of Care
Placebo	Placebo comparator	Participants received matching placebo tablets twice a day in addition to standard heart failure therapy. Receives: Drug: Placebo; Drug: Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Cardiovascular Death or First Heart Failure Event
The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis.
A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy.
All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials.
Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
Measured: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Secondary outcomes (4)

Time to Cardiovascular Death
Cardiovascular death includes acute myocardial infarction (MI), sudden cardiac death, death due to heart failure, death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.
All deaths were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.
Time to cardiovascular death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.
Measured: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
The Kansas City Cardiomyopathy Questionnaire is a self-administered questionnaire with a 2-week recall period that includes 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy (the patient's understanding of how to manage their heart failure). The symptom frequency and symptom burden domains are merged into a total symptom score. Scores are represented on a 0-to-100-point scale, where lower scores represent more frequent and severe symptoms and scores of 100 indicate no symptoms.
The change from baseline in KCCQ TSS was analyzed separately for each randomization setting (inpatient and outpatient).
Least squares means are from the mixed model which includes baseline total symptom score value, region, baseline eGFR, scheduled visit, treatment group and interaction of treatment with scheduled visit as covariates.
Measured: Baseline and Week 24
Time to First Heart Failure Hospitalization
A HF hospitalization is defined as an event that met all of the following criteria:
1. The participant was admitted to the hospital with a primary diagnosis of HF;
2. The length of stay in the hospital extended for at least 24 hours;
3. The participant exhibited documented new or worsening symptoms due to HF on presentation;
4. The participant had objective evidence of new or worsening HF;
5. The participant received initiation or intensification of treatment specifically for HF, including an intravenous diuretic or vasoactive agent, mechanical or surgical intervention, or mechanical fluid removal.
Events were adjudicated by an independent external CEC at the Duke Clinical Research Institute using standardized definitions based on the ACC/AHA standards for endpoint definitions in CV clinical trials.
Time to first HF hospitalization was analyzed using KM methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event is reported.
Measured: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Time to All-cause Death
All events were adjudicated by an independent external clinical-events committee at the Duke Clinical Research Institute, using standardized definitions based on the recent ACC/AHA standards for endpoint definitions in cardiovascular clinical trials.
Time to all-cause death was analyzed using Kaplan-Meier methods. Since the median was not calculated, the percentage of participants with an event are reported. Events that occurred up to the earliest of last confirmed survival status date or analysis cut-off date (07 August 2020) are included.
Measured: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 201714 Sep 2020

First posted11 Oct 2016 (estimated)
Study start6 Jan 2017
Primary completion14 Sep 2020
Study completion14 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 8,256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02929329
Sponsor's protocol ID: 20110203
Other IDs: 2016-002299-28, 2016
Acronym: GALACTIC-HF
Status last verified: Nov 2021
First submitted: 30 Sep 2016
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Publications

Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.
PubMed 34015475
Ono R, Docherty KF, Henderson AD, Echeverria LE, Felker GM, Lopes RD, Martinez F, Packer M, Ramires FJA, Teerlink JR, Vaduganathan M, Zile MR, Jhund PS, Solomon SD, McMurray JJV. Comparative Prognosis of Chagas and Other Cardiomyopathies. J Am Coll Cardiol. 2026 Jun 30;87(25):3521-3535. doi: 10.1016/j.jacc.2026.03.022. Epub 2026 Mar 16.
PubMed 41847775
Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Tolomeo P, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Dipstick proteinuria and outcomes in patients with heart failure and reduced ejection fraction: insights from GALACTIC-HF. Eur J Heart Fail. 2026 May 11;28(2):249-259. doi: 10.1093/ejhf/xuag003.
PubMed 41771088
Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Lactate Dehydrogenase and Outcomes in Patients With HF and Reduced Ejection Fraction: Insights From GALACTIC-HF. JACC Heart Fail. 2026 May;14(5):102900. doi: 10.1016/j.jchf.2025.102900. Epub 2026 Jan 13.
PubMed 41528277
Lu H, Claggett BL, Felker GM, McMurray JJV, Teerlink JR, Inciardi RM, Metra M, Heitner SB, Diaz R, Malik F, Vaduganathan M, Solomon SD. Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction According to Age: The GALACTIC-HF Trial. JACC Heart Fail. 2026 Feb;14(2):102703. doi: 10.1016/j.jchf.2025.102703. Epub 2025 Oct 22.
PubMed 41123512
Felker GM, Solomon SD, Metra M, Mcmurray JJV, Diaz R, Claggett B, Lanfear DE, Vandekerckhove H, Biering-Sorensen T, Lopes RD, Arias-Mendoza A, Momomura SI, Corbalan R, Ramires FJA, Zannad F, Heitner SB, Divanji PH, Kupfer S, Malik FI, Teerlink JR. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil: Results From the GALACTIC-HF Study. J Card Fail. 2024 Jun;30(6):755-763. doi: 10.1016/j.cardfail.2023.11.021. Epub 2024 Jan 11.
PubMed 38215932
Pabon M, Cunningham J, Claggett B, Felker GM, McMurray JJV, Metra M, Diaz R, Wang X, Arias-Mendoza A, Bonderman D, Crespo-Leiro M, Fonseca C, Goncalvesova E, Lund M, O'Meara E, Sliwa-Hahnle K, Malik FI, Solomon SD, Teerlink JR; GALACTIC-HF Investigators. Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial. JACC Heart Fail. 2023 Dec;11(12):1729-1738. doi: 10.1016/j.jchf.2023.07.029. Epub 2023 Oct 11.
PubMed 37831045
Docherty KF, McMurray JJV, Claggett BL, Miao ZM, Adams KF, Arias-Mendoza A, Cleland JGF, Diaz R, Echeverria Correa LE, Felker GM, Fonseca C, Li J, Metra M, Sliwa-Hahnle K, Solomon SD, Vandekerckhove HJ, Vinereanu D, Voors AA, Heitner SB, Kupfer S, Malik FI, Meng L, Teerlink JR. Efficacy of omecamtiv mecarbil in heart failure with reduced ejection fraction according to N-terminal pro-B-type natriuretic peptide level: insights from the GALACTIC-HF trial. Eur J Heart Fail. 2023 Feb;25(2):248-259. doi: 10.1002/ejhf.2763. Epub 2023 Jan 16.
PubMed 36597719
Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144.
PubMed 35325102
Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.
PubMed 34643642
Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
PubMed 33185990
Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.
PubMed 32035892

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Omecamtiv Mecarbil on Mortality and Morbidity in Subjects With Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF)
ClinicalTrials.gov ID: NCT02929329
Acronym / sponsor ID: GALACTIC-HF / 20110203
Conditions: Heart Failure
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 8,256 participants (actual)
Lead sponsor: CytokineticsIndustry (pharma, biotech, devices)
Study start: 6 Jan 2017 (actual)
Primary completion: 14 Sep 2020 (actual)
Study completion: 14 Sep 2020 (actual)
First posted: 11 Oct 2016 (estimated)
Results: Posted 20 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Omecamtiv Mecarbil	Experimental	Drug: Omecamtiv Mecarbil, Drug: Standard of CareParticipants received oral omecamtiv mecarbil (OM) twice daily in addition to standard heart failure therapy. The starting dose of OM was 25 mg; At week 4, participants with week 2 OM predose plasma concentrations < 200 ng/mL had their dose increased to 50 mg BID; participants with week 2 predose plasma concentrations ≥ 200 and < 300 ng/mL had their dose increased to 37.5 mg BID and participants with week 2 predose plasma concentrations ≥ 300 ng/mL and < 1000 ng/mL maintained a 25 mg BID dosing regimen.
Placebo	Placebo comparator	Drug: Placebo, Drug: Standard of CareParticipants received matching placebo tablets twice a day in addition to standard heart failure therapy.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Subject has provided informed consent
Male or female, ≥ 18 to ≤ 85 years
History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 30 days before randomization
Left ventricle ejection fraction (LVEF) ≤ 35%, per subjects most recent medical record, within 12 months prior to screening.
New York Heart Association (NYHA) class II to IV at most recent screening assessment.

Key exclusion criteria (4 listed)

Currently receiving treatment in another investigational device or drug study, or < 30 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.
Malignancy within 5 years prior to randomization with the following exceptions: localized basal or squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, stage 1 prostate carcinoma, breast ductal carcinoma in situ.
Subject has known sensitivity to any of the products or components to be administered during testing
Other Exclusion Criteria May apply

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Omecamtiv MecarbilAlso: AMG 423Omecamtiv mecarbil tablets for oral administration	Drug	Omecamtiv Mecarbil
PlaceboMatching placebo tablets	Drug	Placebo
Standard of CareParticipants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.	Drug	Omecamtiv Mecarbil, Placebo

Primary outcome

Time to Cardiovascular Death or First Heart Failure Event
Time frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
The primary outcome was a composite of a heart-failure (HF) event or cardiovascular (CV) death, whichever occurred first, in a time-to-event analysis. A heart-failure event was defined as an urgent clinic visit, emergency department visit, or hospitalization for subjectively and objectively worsening heart failure leading to treatment intensification beyond a change in oral diuretic therapy. All deaths and HF events were adjudicated by an independent external clinical events committee (CEC) at the Duke Clinical Research Institute, using standardized definitions based on the recent American College of Cardiology/American Heart Association (ACC/AHA) standards for endpoint definitions in cardiovascular clinical trials. Time to cardiovascular death or first HF event was analyzed using Kaplan-Meier (KM) methods. Since the median was not calculated, the percentage of participants with a positively adjudicated event during the study is reported.

4 secondary outcomes

Time to Cardiovascular Death
Time frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Change From Baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ TSS) at Week 24
Time frame: Baseline and Week 24
Time to First Heart Failure Hospitalization
Time frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.
Time to All-cause Death
Time frame: From randomization up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.

Results and safety

Results posted to the registry on 20 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	4,112	3,008
Omecamtiv Mecarbil	4,120	3,028

Primary outcome: Time to Cardiovascular Death or First Heart Failure Event

Time frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.. Number. Unit: percentage of participants

Measure	Placebo n = 4112	Omecamtiv Mecarbil n = 4120
Value	39.1	37.0

Placebo vs Omecamtiv Mecarbil: Hazard Ratio (HR): 0.92 (95% CI 0.86 to 0.99), p = 0.0252, Regression, Cox
Placebo vs Omecamtiv Mecarbil: p = 0.0211, Stratified log-rank test
Placebo vs Omecamtiv Mecarbil: Hazard Ratio (HR): 0.92 (95% CI 0.86 to 0.99)

Population analysed: Full analysis set

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality is reported from randomization until end of study (27 August 2020); median (min, max) time on study was 21.8 (0, 42) months. Adverse events are reported from first dose of study drug until 30 days after last dose; median (min, max) treatment duration was 19.5 (0, 42) months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2,435 of 4,101 (59.4%)	1,146 of 4,101 (27.9%)	1,078 of 4,112
Omecamtiv Mecarbil	2,373 of 4,110 (57.7%)	1,129 of 4,110 (27.5%)	1,078 of 4,120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34015475Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Biering-Sorensen T, Bohm M, Bonderman D, Fang JC, Lanfear DE, Lund M, Momomura SI, O'Meara E, Ponikowski P, Spinar J, Flores-Arredondo JH, Claggett BL, Heitner SB, Kupfer S, Abbasi SA, Malik FI; GALACTIC-HF Investigators. Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF. J Am Coll Cardiol. 2021 Jul 13;78(2):97-108. doi: 10.1016/j.jacc.2021.04.065. Epub 2021 May 17.
Derived from this study: PubMed 41847775Ono R, Docherty KF, Henderson AD, Echeverria LE, Felker GM, Lopes RD, Martinez F, Packer M, Ramires FJA, Teerlink JR, Vaduganathan M, Zile MR, Jhund PS, Solomon SD, McMurray JJV. Comparative Prognosis of Chagas and Other Cardiomyopathies. J Am Coll Cardiol. 2026 Jun 30;87(25):3521-3535. doi: 10.1016/j.jacc.2026.03.022. Epub 2026 Mar 16.
Derived from this study: PubMed 41771088Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Tolomeo P, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Dipstick proteinuria and outcomes in patients with heart failure and reduced ejection fraction: insights from GALACTIC-HF. Eur J Heart Fail. 2026 May 11;28(2):249-259. doi: 10.1093/ejhf/xuag003.
Derived from this study: PubMed 41528277Ono R, Chimura M, Docherty KF, Jhund PS, Yang M, Henderson AD, Metra M, Liu G, Divanji PH, Heitner SB, Kupfer S, Malik FI, Felker GM, Solomon SD, Teerlink JR, McMurray JJV. Lactate Dehydrogenase and Outcomes in Patients With HF and Reduced Ejection Fraction: Insights From GALACTIC-HF. JACC Heart Fail. 2026 May;14(5):102900. doi: 10.1016/j.jchf.2025.102900. Epub 2026 Jan 13.
Derived from this study: PubMed 41123512Lu H, Claggett BL, Felker GM, McMurray JJV, Teerlink JR, Inciardi RM, Metra M, Heitner SB, Diaz R, Malik F, Vaduganathan M, Solomon SD. Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure With Reduced Ejection Fraction According to Age: The GALACTIC-HF Trial. JACC Heart Fail. 2026 Feb;14(2):102703. doi: 10.1016/j.jchf.2025.102703. Epub 2025 Oct 22.
Derived from this study: PubMed 38215932Felker GM, Solomon SD, Metra M, Mcmurray JJV, Diaz R, Claggett B, Lanfear DE, Vandekerckhove H, Biering-Sorensen T, Lopes RD, Arias-Mendoza A, Momomura SI, Corbalan R, Ramires FJA, Zannad F, Heitner SB, Divanji PH, Kupfer S, Malik FI, Teerlink JR. Cardiac Troponin and Treatment Effects of Omecamtiv Mecarbil: Results From the GALACTIC-HF Study. J Card Fail. 2024 Jun;30(6):755-763. doi: 10.1016/j.cardfail.2023.11.021. Epub 2024 Jan 11.
Derived from this study: PubMed 37831045Pabon M, Cunningham J, Claggett B, Felker GM, McMurray JJV, Metra M, Diaz R, Wang X, Arias-Mendoza A, Bonderman D, Crespo-Leiro M, Fonseca C, Goncalvesova E, Lund M, O'Meara E, Sliwa-Hahnle K, Malik FI, Solomon SD, Teerlink JR; GALACTIC-HF Investigators. Sex Differences in Heart Failure With Reduced Ejection Fraction in the GALACTIC-HF Trial. JACC Heart Fail. 2023 Dec;11(12):1729-1738. doi: 10.1016/j.jchf.2023.07.029. Epub 2023 Oct 11.
Derived from this study: PubMed 36597719Docherty KF, McMurray JJV, Claggett BL, Miao ZM, Adams KF, Arias-Mendoza A, Cleland JGF, Diaz R, Echeverria Correa LE, Felker GM, Fonseca C, Li J, Metra M, Sliwa-Hahnle K, Solomon SD, Vandekerckhove HJ, Vinereanu D, Voors AA, Heitner SB, Kupfer S, Malik FI, Meng L, Teerlink JR. Efficacy of omecamtiv mecarbil in heart failure with reduced ejection fraction according to N-terminal pro-B-type natriuretic peptide level: insights from the GALACTIC-HF trial. Eur J Heart Fail. 2023 Feb;25(2):248-259. doi: 10.1002/ejhf.2763. Epub 2023 Jan 16.
Derived from this study: PubMed 35325102Solomon SD, Claggett BL, Miao ZM, Diaz R, Felker GM, McMurray JJV, Metra M, Corbalan R, Filippatos G, Goudev AR, Mareev V, Serpytis P, Suter T, Yilmaz MB, Zannad F, Kupfer S, Heitner SB, Malik FI, Teerlink JR. Influence of atrial fibrillation on efficacy and safety of omecamtiv mecarbil in heart failure: the GALACTIC-HF trial. Eur Heart J. 2022 Jun 14;43(23):2212-2220. doi: 10.1093/eurheartj/ehac144.
Derived from this study: PubMed 34643642Felker GM, Solomon SD, Claggett B, Diaz R, McMurray JJV, Metra M, Anand I, Crespo-Leiro MG, Dahlstrom U, Goncalvesova E, Howlett JG, MacDonald P, Parkhomenko A, Tomcsanyi J, Abbasi SA, Heitner SB, Hucko T, Kupfer S, Malik FI, Teerlink JR. Assessment of Omecamtiv Mecarbil for the Treatment of Patients With Severe Heart Failure: A Post Hoc Analysis of Data From the GALACTIC-HF Randomized Clinical Trial. JAMA Cardiol. 2022 Jan 1;7(1):26-34. doi: 10.1001/jamacardio.2021.4027.
Derived from this study: PubMed 33185990Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Adams KF, Anand I, Arias-Mendoza A, Biering-Sorensen T, Bohm M, Bonderman D, Cleland JGF, Corbalan R, Crespo-Leiro MG, Dahlstrom U, Echeverria LE, Fang JC, Filippatos G, Fonseca C, Goncalvesova E, Goudev AR, Howlett JG, Lanfear DE, Li J, Lund M, Macdonald P, Mareev V, Momomura SI, O'Meara E, Parkhomenko A, Ponikowski P, Ramires FJA, Serpytis P, Sliwa K, Spinar J, Suter TM, Tomcsanyi J, Vandekerckhove H, Vinereanu D, Voors AA, Yilmaz MB, Zannad F, Sharpsten L, Legg JC, Varin C, Honarpour N, Abbasi SA, Malik FI, Kurtz CE; GALACTIC-HF Investigators. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure. N Engl J Med. 2021 Jan 14;384(2):105-116. doi: 10.1056/NEJMoa2025797. Epub 2020 Nov 13.
Derived from this study: PubMed 32035892Teerlink JR, Diaz R, Felker GM, McMurray JJV, Metra M, Solomon SD, Legg JC, Buchele G, Varin C, Kurtz CE, Malik FI, Honarpour N. Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF. JACC Heart Fail. 2020 Apr;8(4):329-340. doi: 10.1016/j.jchf.2019.12.001. Epub 2020 Feb 6.
AmgenTrials clinical trials websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

MD study director

Amgen

1,033 sites in 36 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Omecamtiv Mecarbil in people with Heart Failure, run by Cytokinetics at 1,033 sites in 36 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1,033 sites in United States, Japan, China, Russia, Argentina and 31 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Cardiovascular Death or First Heart Failure Event (time frame: From randomization to up to earliest of last confirmed survival status date or analysis cut-off date (07 August 2020); the overall median duration of follow-up was 21.8 months up to a maximum of 42 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02929329, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.