Heart FailurePhase 3NCT00358215

RED-HF™ Trial - Reduction of Events With Darbepoetin Alfa in Heart Failure Trial

A Phase 3 study testing Darbepoetin alfa in people with Heart Failure and Anemia, run by Amgen at 754 sites in 36 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to determine the efficacy of treatment of anemia with darbepoetin alfa compared to placebo on the composite of time to death from any cause or first hospital admission for worsening heart failure in patients with symptomatic left ventricular systolic dysfunction and anemia. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure, Anemia, Cardiovascular Disease
What is being tested?: Darbepoetin alfa
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,278 participants
Where: 754 sitesin 36 countries
Study dates: 1 Jun 2006to 11 Oct 2012
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
hemoglobin between 9.0 g/dL and 12.0 g/dL
left ventricular ejection fraction equal to or less than 40%

Who cannot join

Transferrin saturation (Tsat) < 15%
Blood pressure > 160/100 mm Hg
Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
Recipient of a major organ transplant or receiving renal replacement therapy
Serum creatinine > 3.0 mg/dL (> 265 µmol/L)

Trial locations and contacts

754 sites in 36 countries.

Country

City, postcode or hospital

754 sites in 36 countries

United States254 sites

Research Site
Akron, Ohio, 44307
Research Site
Albuquerque, New Mexico, 87131
Research Site
Alexandria, Louisiana, 71301
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Allentown, Pennsylvania, 18106
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Anaheim, California, 92801
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Anderson, Indiana, 46011
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Anderson, South Carolina, 29621
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Annandale, Virginia, 22003
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Annapolis, Maryland, 21401
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30308
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30901
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Aurora, Colorado, 80012
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Ayer, Massachusetts, 01432
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Baltimore, Maryland, 21287
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Beaumont, Texas, 77702
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Bellingham, Washington, 98225
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Beloit, Wisconsin, 53511
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Bend, Oregon, 97701
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Birmingham, Alabama, 35211
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Birmingham, Alabama, 35294
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Boston, Massachusetts, 02115
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Boston, Massachusetts, 02118
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Bridgeport, Connecticut, 06606
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Buena Park, California, 90621
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Buffalo, New York, 14221
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Burlington, North Carolina, 27215
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Canton, Ohio, 44710
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Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29401
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Charleston, South Carolina, 29403
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Charlotte, North Carolina, 28204
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Chattanooga, Tennessee, 37404
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Chicago, Illinois, 60611
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Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44106
Research Site
Cleveland, Ohio, 44109
Research Site
Cleveland, Ohio, 44195
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Colorado Springs, Colorado, 80907
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Columbia, Missouri, 65201
Research Site
Columbia, South Carolina, 29204
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Corona, California, 92879
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Cortlandt Manor, New York, 10567
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Covington, Georgia, 30014
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Covington, Louisiana, 70433
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Culver City, California, 90232
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Dallas, Texas, 75216
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Dallas, Texas, 75226
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Dallas, Texas, 75230
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Dallas, Texas, 75231
Research Site
Dallas, Texas, 75390
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Dayton, Ohio, 45414
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Denver, Colorado, 80218
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Des Moines, Iowa, 50314
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Downey, California, 90241
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Duluth, Minnesota, 55805
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Durham, North Carolina, 27705
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Elk Grove Village, Illinois, 60007
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Evanston, Illinois, 60202
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Fairfield, Connecticut, 06430
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Flushing, New York, 11355
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Fort Wayne, Indiana, 46805
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Galveston, Texas, 77555
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Garden City, New York, 11530
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Garfield Heights, Ohio, 44125
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Gastonia, North Carolina, 28054
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Germantown, Tennessee, 38138
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Gilbert, Arizona, 85296
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Grand Island, Nebraska, 68803
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Grand Rapids, Michigan, 49503
Research Site
Greensboro, North Carolina, 27403
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Hackensack, New Jersey, 07601
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Haverhill, Massachusetts, 01830
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Hershey, Pennsylvania, 17033
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Hillsboro, Oregon, 97123
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Hinsdale, Illinois, 60521
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Houston, Texas, 77004
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77074
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202
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Indianapolis, Indiana, 46250
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Indianapolis, Indiana, 46260
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Iowa City, Iowa, 52242
Research Site
Iowa City, Iowa, 52245
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Jackson, Tennessee, 38305
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Jacksonville, Florida, 32207
Research Site
Jacksonville, Florida, 32209
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Jacksonville, Florida, 32258
Research Site
Jacksonville Beach, Florida, 32250
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Jeffersonville, Indiana, 47130
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Johnson City, New York, 13790
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Jupiter, Florida, 33458
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Kalispell, Montana, 59901
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Kansas City, Kansas, 66160
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Kansas City, Missouri, 64108
Research Site
Kansas City, Missouri, 64111
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Kingston, New York, 12401
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Kirkland, Washington, 98034
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La Jolla, California, 92037
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Lake Charles, Louisiana, 70601
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Lancaster, California, 93534
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Lancaster, Pennsylvania, 17603
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Lansing, Michigan, 48910
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Larkspur, California, 94939
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Lebanon, New Hampshire, 03756
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Lincoln, Nebraska, 68506
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Lincoln, Nebraska, 68526
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Little Rock, Arkansas, 72204
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Little Rock, Arkansas, 72205
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Littleton, Colorado, 80120
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Loma Linda, California, 92354
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Long Beach, California, 90822
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Los Angeles, California, 90017
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Los Angeles, California, 90024
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Los Angeles, California, 90033-1026
Research Site
Los Angeles, California, 90048
Research Site
Los Angeles, California, 90073
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Louisville, Kentucky, 40202
Research Site
Louisville, Kentucky, 40207
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Loveland, Colorado, 80538
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Lubbock, Texas, 79410
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Madison, Wisconsin, 53707
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Madison, Wisconsin, 53792
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Madisonville, Kentucky, 42431
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Marrero, Louisiana, 70072
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Mayfield Heights, Ohio, 44124
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Maywood, Illinois, 60153
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Melbourne, Florida, 32901
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Melrose Park, Illinois, 60160
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Memphis, Tennessee, 38104
Research Site
Memphis, Tennessee, 38120
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Meridian, Idaho, 83642
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Mesa, Arizona, 85206
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Miami, Florida, 33133
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Miami Beach, Florida, 33140
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Midlothian, Virginia, 23114
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Milwaukee, Wisconsin, 53215
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Minneapolis, Minnesota, 55304
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Minneapolis, Minnesota, 55417
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Minneapolis, Minnesota, 55455
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Missoula, Montana, 59802
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Mobile, Alabama, 36608
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Modesto, California, 95355
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Morristown, New Jersey, 07962
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Muskegon, Michigan, 49444
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232-8802
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Natick, Massachusetts, 01760
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New Bern, North Carolina, 28562
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New York, New York, 10001
Research Site
New York, New York, 10016
Research Site
New York, New York, 10019
Research Site
New York, New York, 10021
Research Site
New York, New York, 10029
Research Site
New York, New York, 10032
Research Site
Newark, New Jersey, 07103
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Newark, New Jersey, 07112
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North Dartmouth, Massachusetts, 02747
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Oak Lawn, Illinois, 60453
Research Site
Oakbrook Terrace, Illinois, 60181
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Oakland, California, 94609
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Odessa, Texas, 79763
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Oklahoma City, Oklahoma, 73104
Research Site
Oklahoma City, Oklahoma, 73109
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Oklahoma City, Oklahoma, 73112
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Oklahoma City, Oklahoma, 73120
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Olathe, Kansas, 66061
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Orangeburg, South Carolina, 29115
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Orlando, Florida, 32803
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Pasadena, California, 91105
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Pawtucket, Rhode Island, 02860
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Peoria, Illinois, 61606
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Petoskey, Michigan, 49770
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Philadelphia, Pennsylvania, 19102
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Philadelphia, Pennsylvania, 19107
Research Site
Philadelphia, Pennsylvania, 19140
Research Site
Philadelphia, Pennsylvania, 19141
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Pittsburgh, Pennsylvania, 15212
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Pittsburgh, Pennsylvania, 15213
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Pittsburgh, Pennsylvania, 15224
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Port Charlotte, Florida, 33952
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Portland, Oregon, 97213
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Redondo Beach, California, 90277
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Richmond, Virginia, 23249
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Roanoke, Virginia, 24014
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Rochester, New York, 14618
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Rockford, Illinois, 61107
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Rome, Georgia, 30165
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Sacramento, California, 95819
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Sacramento, California, 95825
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Safety Harbor, Florida, 34695
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Saginaw, Michigan, 48601
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Saint Louis Park, Minnesota, 55426
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Saint Paul, Minnesota, 55102
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Salisbury, Maryland, 21804
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Salt Lake City, Utah, 84148
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San Antonio, Texas, 78217
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San Diego, California, 92120
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San Francisco, California, 94115
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San Francisco, California, 94118
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Sandusky, Ohio, 44870
Research Site
Santa Monica, California, 90404
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Santa Rosa, California, 95405
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Sarasota, Florida, 34239
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Sayre, Pennsylvania, 18840
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Scottsdale, Arizona, 85251
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Seattle, Washington, 98195
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Slidell, Louisiana, 70458
Research Site
South Portland, Maine, 04106
Research Site
Southfield, Michigan, 48075
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Spartanburg, South Carolina, 29303
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Springfield, Illinois, 62701
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Springfield, Illinois, 62702
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St Louis, Missouri, 63104
Research Site
St Louis, Missouri, 63110
Research Site
St Louis, Missouri, 63122
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St. Petersburg, Florida, 33701
Research Site
St. Petersburg, Florida, 33705
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Staten Island, New York, 10305
Research Site
Summit, New Jersey, 07902
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Sylmar, California, 91342
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Syracuse, New York, 13210
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Tacoma, Washington, 98405
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Tamarac, Florida, 33321
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Tampa, Florida, 33609
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The Bronx, New York, 10461
Research Site
The Bronx, New York, 10467
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Toledo, Ohio, 43606
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Troy, New York, 12180
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Tucson, Arizona, 85723
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Tullahoma, Tennessee, 37388
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Tulsa, Oklahoma, 74104
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Tyler, Texas, 75708
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Valparaiso, Indiana, 46383
Research Site
Walnut Creek, California, 94598
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Washington D.C., District of Columbia, 20010
Research Site
Washington D.C., District of Columbia, 20422
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West Islip, New York, 11795
Research Site
West Roxbury, Massachusetts, 02132
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Westlake Village, California, 91361
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Westwood, New Jersey, 07675
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Whitman, Massachusetts, 02382
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Wichita, Kansas, 67214
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Williamsville, New York, 14221
Research Site
Winston-Salem, North Carolina, 27103
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Worcester, Massachusetts, 01604
Research Site
Worcester, Massachusetts, 01655
Research Site
Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada31 sites

Research Site
Ajax, Ontario, L1S 7K8
Research Site
Calgary, Alberta, T2E 7C5
Research Site
Cambridge, Ontario, N1R 7R1
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Campbell River, British Columbia, V9W 5Y4
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Edmonton, Alberta, T6G 2B7
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Edmonton, Alberta, T6K 4C1
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Halifax, Nova Scotia, B3H 3A7
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Hamilton, Ontario, L8L 2X2
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Kingston, Ontario, K7L 1C2
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London, Ontario, N6A 5A5
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Mississauga, Ontario, L5B 4A2
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Montreal, Quebec, H1T 2M4
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Montreal, Quebec, H2W 1T7
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Montreal, Quebec, H2W 1T8
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Montreal, Quebec, H3A 1A1
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Montreal, Quebec, H3G 1A4
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North York, Ontario, M2K 2W2
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Ottawa, Ontario, K1Y 4W7
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Regina, Saskatchewan, S4P 3X3
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Saskatoon, Saskatchewan, S7H 5H9
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Scarborough Village, Ontario, M1E 5E9
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Scarborough Village, Ontario, M1P 2V5
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Sherbrooke, Quebec, J1H 5N4
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St-JÃ©rÃ´me, Quebec, J7Z 5T3
Research Site
St. John's, Newfoundland and Labrador, A1B 3V6
Research Site
Surrey, British Columbia, V3V 1Z2
Research Site
Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 1X5
Research Site
Toronto, Ontario, M5G 2C4
Research Site
Winnipeg, Manitoba, R3C 0N2
Research Site
Winnipeg, Manitoba, R3T 2E8

Other trials in Canada

India30 sites

Research Site
Ahmedabad, Gujarat, 380 006
Research Site
Ahmedabad, Gujarat, 380 060
Research Site
Ahmedabad, Gujarat, 382 428
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Bangalore, Karnataka, 560 034
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Bangalore, Karnataka, 560 054
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Bikaner, Rajasthan, 334 003
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Chennai, Tamil Nadu, 600 006
Research Site
Chennai, Tamil Nadu, 600 037
Research Site
Chennai, Tamil Nadu, 600 081
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Coimbatore, Tamil Nadu, 641 004
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Coimbatore, Tamil Nadu, 641 014
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Gurgaon, Haryana, 122 001
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Hyderabad, Andhra Pradesh, 500 001
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Hyderabad, Andhra Pradesh, 500 033
Research Site
Hyderabad, Andhra Pradesh, 500 063
Research Site
Lucknow, Uttar Pradesh, 226 014
Research Site
Ludhiana, Punjab, 141 001
Research Site
Madurai, Tamil Nadu, 625 020
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Mumbai, Maharashtra, 400 022
Research Site
Mumbai, 400 020
Research Site
Nagpur, Maharashtra, 400 012
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Nashik, Maharashtra, 422 005
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New Delhi, National Capital Territory of Delhi, 110 025
Research Site
New Delhi, National Capital Territory of Delhi, 110 029
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Pune, Maharashtra, 411 001
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Pune, Maharashtra, 411 004
Research Site
Pune, Maharashtra, 411 006
Research Site
Pune, Maharashtra, 411 011
Research Site
Pune, Maharashtra, 411 016
Research Site
Pune, Maharashtra, 411 033

Other trials in India

Argentina27 sites

Research Site
Adrogué, Buenos Aires, 1836
Research Site
Bahía Blanca, Buenos Aires, 8000
Research Site
Buenos Aires, 1155
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Buenos Aires, B1708KCH
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Buenos Aires, C1181ACH
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Buenos Aires, C1280AEB
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Buenos Aires, C1405BCH
Research Site
Buenos Aires, C1416DRJ
Research Site
Capital Federal, Buenos Aires, C1408INH
Research Site
Capital Federal, Buenos Aires, C1426ANZ
Research Site
Capital Federal, C1221ADC
Research Site
Cipolletti, RÃ-o Negro, R8324EMD
Research Site
Ciudad AutÃ³noma de Buenos Aires, Buenos Aires, 1118
Research Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1425
Research Site
Córdoba, CÃ³rdoba, X5016KEH
Research Site
Córdoba, 5000
Research Site
Córdoba, X5004CDT
Research Site
Coronel Suárez, Buenos Aires, 7540
Research Site
Corrientes, W3400AMZ
Research Site
La Plata, Buenos Aires, 1900
Research Site
Mar del Plata, Buenos Aires, B7600FZN
Research Site
Mendoza, 5500
Research Site
Quilmes, Buenos Aires, B1878GEG
Research Site
Rosario, Santa Fe Province, S2000CVD
Research Site
Salta, A4406CLA
Research Site
San Martín, Buenos Aires, 1650
Research Site
Santa Fe, 3000

Other trials in Argentina

Netherlands26 sites

Research Site
's-Hertogenbosch, 5211 RW
Research Site
Alkmaar, 1815 JD
Research Site
Almelo, 7609 PP
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Amsterdam, 1091 AC
Research Site
Arnhem, 6815 AD
Research Site
Assen, 9401 RK
Research Site
Blaricum, 1261 AN
Research Site
Breda, 4818 CK
Research Site
Delft, 2625 AD
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Deventer, 7416 SE
Research Site
Eindhoven, 5623 EJ
Research Site
Enschede, 7513 ER
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Groningen, 9713 GZ
Research Site
Haarlem, 2035 RC
Research Site
Harderwijk, 3844 DG
Research Site
Heerlen, 6419 PC
Research Site
Hilversum, 1213 XZ
Research Site
Hoorn, 1625 HV
Research Site
Nijmegen, 6532 SZ
Research Site
Rotterdam, 3045 PM
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Rotterdam, 3083 AN
Research Site
Sneek, 8601 ZK
Research Site
The Hague, 2512 VA
Research Site
Tiel, 4002 WP
Research Site
Tilburg, 5042 AD
Research Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Germany25 sites

Research Site
Bad TÃ¶lz, 83646
Research Site
Berlin, 10787
Research Site
Berlin, 12200
Research Site
Berlin, 13353
Research Site
Bochum, 44789
Research Site
Bremen, 28277
Research Site
Frankfurt, 60594
Research Site
GÃ¶ttingen, 37075
Research Site
GeorgsmarienhÃ¼tte, 49124
Research Site
Hamburg, 20148
Research Site
Hamburg, 20246
Research Site
Hanover, 30625
Research Site
Heidelberg, 69115
Research Site
Heidelberg, 69120
Research Site
Homburg, 66421
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Ingelheim, 55218
Research Site
KÃ¶ln, 50924
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Lahr, 77933
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Leipzig, 04289
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Mainz, 55131
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Marburg, 35037
Research Site
NÃ¼rnberg, 90402
Research Site
Schwedt, 16303
Research Site
Stuttgart, 70376
Research Site
Witten, 58455

Other trials in Germany

Russia24 sites

Research Site
Moscow, 107014
Research Site
Moscow, 109263
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Moscow, 115093
Research Site
Moscow, 115516
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Moscow, 117292
Research Site
Moscow, 117513
Research Site
Moscow, 119435
Research Site
Moscow, 119620
Research Site
Moscow, 119992
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Moscow, 121359
Research Site
Moscow, 121552
Research Site
Moscow, 125206
Research Site
Moscow, 125315
Research Site
Moscow, 127018
Research Site
Moscow, 127473
Research Site
Moscow, 127644
Research Site
Moscow, 129090
Research Site
Saint Petersburg, 192242
Research Site
Saint Petersburg, 194017
Research Site
Saint Petersburg, 194156
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 198205
Research Site
Saint Petersburg, 199106
Research Site
Volgograd, 400008

Other trials in Russia

United Kingdom22 sites

Research Site
Barnet, EN5 3DJ
Research Site
Belfast, BT12 6BA
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Birmingham, B757RR
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Bradford, BD9 6RJ
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Bridlington, YO164QP
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Cottingham, HU16 5JQ
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Coventry, CV2 2DX
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Glasgow, G12 8TA
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Glasgow, G51 4TF
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Harrow, HA1 3UJ
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Kirkcaldy, KY2 5AH
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Leeds, LS1 3EX
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Leeds, LS9 7TF
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Leicester, LE3 9QP
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Livingston, EH54 6PP
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London, SE1 7EH
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Manchester, M8 5RB
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Romford, RM7 0AG
Research Site
Stockport, SK2 7JE
Research Site
Worcester, WR5 1DD
Research Site
Worthing, BN11 2DH
Research Site
York, YO31 8HE

Other trials in United Kingdom

Italy21 sites

Research Site
Arezzo, 52100
Research Site
Bergamo, 24128
Research Site
Cesenatico (FC), 47042
Research Site
Cetraro CS, 87022
Research Site
Cortona AR, 52044
Research Site
Eboli, 84025
Research Site
Ferrara, 44100
Research Site
ForlÃ¬, 47100
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Milan, 20138
Research Site
Naples, 80131
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Oliveto Citra SA, 84020
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Palermo, 90126
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Palmanova UD, 33057
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Pavia, 27100
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Roma, 00152
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Roma, 00184
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Rozzano MI, 20089
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San Bonifacio VR, 37047
Research Site
Torino, 10126
Research Site
Trento, 38100
Research Site
Udine, 33100

Other trials in Italy

France20 sites

Research Site
Bron, 69500
Research Site
Caen, 14033
Research Site
Cholet, 49325
Research Site
CrÃ©teil Cedex, 94010
Research Site
Douai, 59507
Research Site
Grenoble, 38043
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Lille, 59037
Research Site
Montfermeil, 93370
Research Site
Montpellier, 34295
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Nice, 06002
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Paris, 75010
Research Site
Paris, 75651
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Pessac, 33604
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Poitiers, 86000
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Pontoise, 95301
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Rouen, 76031
Research Site
Saint-Herblain, 44800
Research Site
Strasbourg, 67091
Research Site
Toulouse, 31403
Research Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain20 sites

Research Site
Badalona, CataluÃ±a, 08916
Research Site
Barcelona, CataluÃ±a, 08003
Research Site
Barcelona, CataluÃ±a, 08035
Research Site
Barcelona, CataluÃ±a, 08036
Research Site
Barcelona, CataluÃ±a, 08041
Research Site
CÃ³rdoba, AndalucÃ-a, 14004
Research Site
El Palmar, Murcia, 30120
Research Site
Galdakao, PaÃ-s Vasco, 48960
Research Site
Granada, AndalucÃ-a, 18014
Research Site
MÃ¡laga, AndalucÃ-a, 29010
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Madrid, 28046
Research Site
Majadhonda, Madrid, 28222
Research Site
Oviedo, Principality of Asturias, 33006
Research Site
Sabadell, CataluÃ±a, 08208
Research Site
Santander, Cantabria, 39008
Research Site
Santiago de Compostela, Galicia, 15706
Research Site
Tarragona, CataluÃ±a, 43007
Research Site
Valencia, Valencia, 46014

Other trials in Spain

Poland19 sites

Research Site
Bialystok, 15-276
Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-423
Research Site
Gdynia, 81-519
Research Site
Katowice, 40-635
Research Site
Krakow, 30-092
Research Site
Krakow, 31-202
Research Site
Lublin, 20-954
Research Site
Stalowa Wola, 37-450
Research Site
Tarnów, 33-100
Research Site
Wałbrzych, 58-309
Research Site
Warsaw, 01-211
Research Site
Warsaw, 01-809
Research Site
Warsaw, 03-242
Research Site
Warsaw, 04-238
Research Site
Warsaw, 04-628
Research Site
Wroclaw, 50-981
Research Site
Zabrze, 41-800
Research Site
Zielona Góra, 65-046

Other trials in Poland

Brazil18 sites

Research Site
Belo Horizonte, Minas Gerais, 30110-908
Research Site
Campinas, SÃ£o Paulo, 13059-740
Research Site
Curitiba, ParanÃ¡, 80010-030
Research Site
Fortaleza, CearÃ¡, 60864-194
Research Site
Goiânia, GoiÃ¡s, 74605-050
Research Site
Porto Alegre, Rio Grande do Sul, 90020-090
Research Site
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About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia

Read the detailed description

Several epidemiological studies have demonstrated an association between HF and anemia and correlation of increased risk for mortality and hospitalization with low hemoglobin in patients with HF. Earlier single-center interventional studies suggest that meaningful clinical benefits may be achieved by raising hemoglobin concentration in patients with symptomatic HF and anemia. Data from Amgen's completed phase 2 multi-center studies support this hypothesis and show that darbepoetin alfa is well tolerated in patients with symptomatic left ventricular systolic dysfunction and anemia and effectively raises hemoglobin. The pivotal phase 3 Study 20050222 RED-HF Trial is evaluating the effect of treatment with darbepoetin alfa on the composite risk of all-cause mortality or hospitalization for worsening HF in patients with symptomatic left ventricular systolic dysfunction and anemia. This study also evaluates the effect of darbepoetin alfa treatment on all-cause death, on cardiovascular death or hospitalization for worsening HF, and on patient-reported quality-of-life outcomes.

Conditions: Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure
Being tested: Darbepoetin alfa, Placebo
Keywords: Survival study, morbidity and mortality, heart failure hospitalization, all-cause death, patient-reported outcomes, Kansas City Cardiomyopathy questionnaire, anemia treatment
Medical subject headings: Heart Failure, Anemia, Cardiovascular Diseases, Ventricular Dysfunction

What participants receive

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

Darbepoetin alfaDrug
Also called Aranesp®
Administered by subcutaneous injection
PlaceboDrug
Placebo subcutaneous injection

Study groups in NCT00358215
Study group	Role	What they receive
Darbepoetin alfa	Experimental	Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL. Receives: Drug: Darbepoetin alfa
Placebo	Placebo comparator	Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa. Receives: Drug: Placebo

What is being measured

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

Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Measured: From randomization to the end of study; maximum time on study was 73 months

Secondary outcomes (4)

Time to Death From Any Cause
Time from randomization to death due to any cause, estimated by the Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Measured: From randomization to the end of study; maximum time on study was 73 months
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
Time to cardiovascular death or first hospital admission for worsening heart failure, whichever occured first, estimated using the Kaplan Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.
Measured: From randomization to the end of study; maximum time on study was 73 months
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Measured: Baseline and Month 6
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
The KCCQ is a disease-specific patient-reported outcomes measure for patients with heart failure. It consists of 23 items, is comprised of 7 clinically relevant scales (Symptom Frequency, Symptom Burden, Symptom Stability, Physical Limitation, Social Limitation, Quality of Life, and Self-Efficacy), and yields 3 summary scores (Clinical Summary, Total Symptom, and Overall Summary Scores). Scale and summary scores range between 0 and 100, with higher scores indicating better health status (eg, better functioning, fewer symptoms, better quality of life). Least squares means were calculated from a mixed effects model estimating treatment effect adjusted for region, type of device, and Baseline KCCQ score.
Measured: Baseline and Month 6

Timeline

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

1 Jun 200611 Oct 2012

First posted31 Jul 2006 (estimated)
Study start1 Jun 2006
Primary completion11 Oct 2012
Study completion11 Oct 2012

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 (5)Papers the sponsor has linked to this study.
Other trials for Heart FailureStudies of the same condition, open and under way.
More trials run by AmgenThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,278 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00358215
Sponsor's protocol ID: 20050222
Other IDs: RED-HF™ Trial
Status last verified: Nov 2022
First submitted: 27 Jul 2006
Last updated: 8 Nov 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098.
PubMed 19633103
Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.
PubMed 23473338
Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
PubMed 36791280
Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.
PubMed 30051179
van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.
PubMed 29367268

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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The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Nov 2022. 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 Darbepoetin Alfa Treatment on Mortality and Morbidity in Heart Failure (HF) Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia
ClinicalTrials.gov ID: NCT00358215
Acronym / sponsor ID: 20050222
Conditions: Heart Failure, Anemia, Cardiovascular Disease, Ventricular Dysfunction, Congestive Heart Failure
Keywords: Survival study, morbidity and mortality, heart failure hospitalization, all-cause death, patient-reported outcomes, Kansas City Cardiomyopathy questionnaire, anemia treatment
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,278 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 1 Jun 2006 (actual)
Primary completion: 11 Oct 2012 (actual)
Study completion: 11 Oct 2012 (actual)
First posted: 31 Jul 2006 (estimated)
Results: Posted 13 Dec 2013

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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Darbepoetin alfa	Experimental	Drug: Darbepoetin alfaStarting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
Placebo	Placebo comparator	Drug: PlaceboParticipants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.

Who may qualify

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

Key inclusion criteria (3 listed)

Heart failure of at least 3 months duration and of New York Heart Association (NYHA) class II, III, or IV
hemoglobin between 9.0 g/dL and 12.0 g/dL
left ventricular ejection fraction equal to or less than 40%

Key exclusion criteria (5 listed)

Transferrin saturation (Tsat) < 15%
Blood pressure > 160/100 mm Hg
Heart failure primarily due to valvular heart disease or clinically significant valvular heart disease that might lead to surgical correction within 12 months of randomization
Recipient of a major organ transplant or receiving renal replacement therapy
Serum creatinine > 3.0 mg/dL (> 265 µmol/L)

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
Darbepoetin alfaAlso: Aranesp®Administered by subcutaneous injection	Drug	Darbepoetin alfa
PlaceboPlacebo subcutaneous injection	Drug	Placebo

Primary outcome

Time to All Cause Death or First Hospitalization for Worsening Heart Failure
Time frame: From randomization to the end of study; maximum time on study was 73 months
Time to death from any cause or first hospital admission for worsening heart failure (adjudicated by the Clinical Endpoint Committee), whichever occurred first, estimated by Kaplan-Meier method. Participants not experiencing a qualifying event during the study were censored at their last contact time or the study termination date, whichever occurred first.

4 secondary outcomes

Time to Death From Any Cause
Time frame: From randomization to the end of study; maximum time on study was 73 months
Time to Cardiovascular Death or First Hospital Admission for Worsening Heart Failure
Time frame: From randomization to the end of study; maximum time on study was 73 months
Change From Baseline to Month 6 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score
Time frame: Baseline and Month 6
Change From Baseline to Month 6 in KCCQ Symptom Frequency Score
Time frame: Baseline and Month 6

Results and safety

Results posted to the registry on 13 Dec 2013, 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	1,142	463
Darbepoetin Alfa	1,136	484

Primary outcome: Time to All Cause Death or First Hospitalization for Worsening Heart Failure

Time frame: From randomization to the end of study; maximum time on study was 73 months. Median (Inter-Quartile Range). Unit: days

Measure	Placebo n = 1142	Darbepoetin Alfa n = 1136
Value	1260.0 (387.0 to 2176.0)	1184.0 (445.0 to 2074.0)

Placebo vs Darbepoetin Alfa: Hazard Ratio (HR): 1.01 (95% CI 0.90 to 1.13), p = 0.871, Stratified Log Rank

Population analysed: Intent-to-treat (ITT) analysis set, defined as all randomized participants

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Informed consent to 30 days post treatment. Max time 72 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	741 of 1,140 (65%)	741 of 1,140 (65%)	Not reported
Darbepoetin Alfa	781 of 1,133 (68.9%)	710 of 1,133 (62.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19633103McMurray JJ, Anand IS, Diaz R, Maggioni AP, O'Connor C, Pfeffer MA, Polu KR, Solomon SD, Sun Y, Swedberg K, Tendera M, van Veldhuisen DJ, Wasserman SM, Young JB; RED-HF Committees and Investigators. Design of the Reduction of Events with Darbepoetin alfa in Heart Failure (RED-HF): a Phase III, anaemia correction, morbidity-mortality trial. Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098.
Background: PubMed 23473338Swedberg K, Young JB, Anand IS, Cheng S, Desai AS, Diaz R, Maggioni AP, McMurray JJ, O'Connor C, Pfeffer MA, Solomon SD, Sun Y, Tendera M, van Veldhuisen DJ; RED-HF Committees; RED-HF Investigators. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. doi: 10.1056/NEJMoa1214865. Epub 2013 Mar 10.
Derived from this study: PubMed 36791280Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3.
Derived from this study: PubMed 30051179Abraityte A, Aukrust P, Kou L, Anand IS, Young J, Mcmurray JJV, van Veldhuisen DJ, Gullestad L, Ueland T. T cell and monocyte/macrophage activation markers associate with adverse outcome, but give limited prognostic value in anemic patients with heart failure: results from RED-HF. Clin Res Cardiol. 2019 Feb;108(2):133-141. doi: 10.1007/s00392-018-1331-2. Epub 2018 Jul 26.
Derived from this study: PubMed 29367268van der Meer P, Grote Beverborg N, Pfeffer MA, Olson K, Anand IS, Westenbrink BD, McMurray JJV, Swedberg K, Young JB, Solomon SD, van Veldhuisen DJ. Hyporesponsiveness to Darbepoetin Alfa in Patients With Heart Failure and Anemia in the RED-HF Study (Reduction of Events by Darbepoetin Alfa in Heart Failure): Clinical and Prognostic Associations. Circ Heart Fail. 2018 Feb;11(2):e004431. doi: 10.1161/CIRCHEARTFAILURE.117.004431.
AmgenTrials clinical trials websiteLink provided by the sponsor.

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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

754 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 Darbepoetin alfa in people with Heart Failure and Anemia, run by Amgen at 754 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 3 inclusion and 5 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 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 754 sites in United States, Canada, India, Argentina, Netherlands 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 13 Dec 2013). 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 All Cause Death or First Hospitalization for Worsening Heart Failure (time frame: From randomization to the end of study; maximum time on study was 73 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 NCT00358215, which also lists 5 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 8 Nov 2022.