Heart FailurePhase 2NCT01300013
Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)
A Phase 2 study testing Omecamtiv mecarbil in people with Heart Failure, run by Cytokinetics at 150 sites in 19 countries.
Trial summary
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. 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
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 150 sitesin 19 countries
- Study dates
- Apr 2011to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Male or female 18 - 85 years
- Hospitalized for worsening heart failure, within 24 hours of initiating IV loop diuretic
- Dyspnea due to heart failure, at rest or with minimal exertion
- History of left ventricular ejection fraction (LVEF) ≤ 40%
- Elevated brain natriuretic peptide (BNP) or N-terminal fragment BNP (NT-proBNP)
Who cannot join
- Receiving IV vasopressor (excluding low dopamine), inotropic or mechanical support
- Acute coronary syndrome (ACS)
- Within 30 days prior to enrollment: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, ACS, coronary revascularization, transient ischemic attack (TIA) or stroke, sustained ventricular arrhythmia, or major surgery
- Severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
Trial locations and contacts
150 sites in 19 countries.
150 sites in 19 countries
United States45 sites
Research Site
Atlanta, Georgia, 30322
Research Site
Atlantis, Florida, 33462
Research Site
Baltimore, Maryland, 21201
Research Site
Chapel Hill, North Carolina, 27599
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Charleston, South Carolina, 29425
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Charlotte, North Carolina, 28204
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Chicago, Illinois, 60611
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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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Clearwater, Florida, 33756
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Cleveland, Ohio, 44109
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Columbus, Ohio, 43210
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Cortlandt Manor, New York, 10567
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Danbury, Connecticut, 06810
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Detroit, Michigan, 48201
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Detroit, Michigan, 48202
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Durham, North Carolina, 27705
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Fairfield, Ohio, 45014
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Fort Lauderdale, Florida, 33308
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Greenville, South Carolina, 29605
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Houston, Texas, 77030
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Inglewood, California, 90301
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La Jolla, California, 92037
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Lincoln, Nebraska, 68506
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Memphis, Tennessee, 38120
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Miami, Florida, 33133
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Minneapolis, Minnesota, 55417
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Mobile, Alabama, 36608
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Murray, Utah, 84107
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232-8802
Research Site
Newark, Delaware, 19718
Research Site
Newark, New Jersey, 07103
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Novi, Michigan, 48374
Research Site
Oklahoma City, Oklahoma, 73120
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Orlando, Florida, 32803
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Peoria, Illinois, 61636
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Portland, Oregon, 97239
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Roslyn, New York, 11576
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San Francisco, California, 94121
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St Louis, Missouri, 63110
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The Bronx, New York, 10467
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Tullahoma, Tennessee, 37388
Research Site
Winston-Salem, North Carolina, 27103
Germany13 sites
Research Site
Bad Nauheim, 61231
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Dortmund, 44137
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Dresden, 01307
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Frankfurt, 60488
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Frankfurt, 60590
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Greifswald, 17475
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Halle, 06097
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Hamburg, 20246
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Homburg, 66421
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Langen, 63225
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Regensburg, 93053
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Stuttgart, 70376
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Würzburg, 97080
Russia13 sites
Research Site
Moscow, 109240
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Moscow, 111539
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Moscow, 115093
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Moscow, 117292
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Moscow, 119620
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Moscow, 119991
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Moscow, 127299
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Moscow, 127473
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Saint Petersburg, 195067
Research Site
Saint Petersburg, 197341
Research Site
Saint Petersburg, 198205
Research Site
Saint Petersburg, 199106
Research Site
St.-Petrsburg, 196247
Canada10 sites
Research Site
Calgary, Alberta, T2N 4Z6
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Edmonton, Alberta, T6G 2B7
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Edmonton, Alberta, T6L 5X8
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Halifax, Nova Scotia, B3H 3A7
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Montreal, Quebec, H3G 1A4
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Ottawa, Ontario, K1Y 4W7
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Québec, Quebec, G1V 4G5
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Sherbrooke, Quebec, J1H 5N4
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Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 1X5
Bulgaria9 sites
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Blagoevgrad, 2700
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Kazanlak, 6100
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Pazardzhik, 4700
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Plovdiv, 4002
Research Site
Sandanski, 2800
Research Site
Smolyan, 4400
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Sofia, 1309
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Sofia, 1431
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Sofia, 1527
France7 sites
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Caen, 14033
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Lille, 59037
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Montpellier, 34295
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Paris, 75010
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Paris, 75651
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Strasbourg, 67091
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Toulouse, 31403
Poland7 sites
Research Site
Bialystok, 15-276
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Gdansk, 80-952
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Krakow, 31-202
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Krakow, 31-501
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Lodz, 91-347
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Lublin, 20-954
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Wroclaw, 50-981
Hungary6 sites
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Budapest, 1023
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Budapest, 1122
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Budapest, 1125
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Budapest, 1134
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Pécs, 7624
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Szolnok, 5004
Australia5 sites
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Bedford Park, South Australia, 5042
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Darlinghurst, New South Wales, 2010
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Prahran, Victoria, 3181
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Richmond, Victoria, 3121
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Woolloongabba, Queensland, 4102
Czechia5 sites
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Brno, 625 00
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Brno, 656 91
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Prague, 128 08
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Prague, 150 06
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Ústí nad Labem, 401 13
Greece5 sites
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Athens, 11528
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Athens, 16673
Research Site
Haidari, 12462
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Heraklion, 71110
Research Site
Pátrai, 26500
Belgium4 sites
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Aalst, 9300
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Bonheiden, 2820
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Ghent, 9000
Research Site
Roeselare, 8800
Italy4 sites
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Brescia, 25125
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Cagliari, 09134
Research Site
Pavia, 27100
Research Site
Udine, 33100
Slovakia4 sites
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Bratislava, 826 06
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Bratislava, 851 07
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Košice, 040 66
Research Site
Nitra, 949 01
United Kingdom4 sites
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Bristol, BS2 8HW
Research Site
Cottingham, HU16 5JQ
Research Site
Glasgow, G11 6NT
Research Site
Harrow, HA1 3UJ
Netherlands3 sites
Research Site
Delft, 2625 AD
Research Site
Deventer, 7416 SE
Research Site
Utrecht, 3584 CX
About this study
Official title: A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.
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
- Placebo, Omecamtiv mecarbil
- Keywords
- Intravenous, IV, Left Ventricular Systolic Dysfunction, Hospitalized, Acute heart failure, Heart failure, Left ventricular ejection fraction, pharmacokinetics, Pharmacodynamics, Dyspnea, hospitalization, In-patient, Omecamtiv mecarbil, Double-blind, Randomized, Placebo-controlled
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
48-hour infusion of placebo
Omecamtiv mecarbilDrug
Also called CK-1827452, AMG 423
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
| Study group | Role | What they receive |
|---|---|---|
| Omecamtiv mecarbil | Experimental | Not described Receives: Drug: Omecamtiv mecarbil |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure.
Measured: 48 hours
Secondary outcomes (3)
To characterize pharmacokinetics of omecamtiv mecarbil including metabolites following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with AHF
Measured: 48 hours
To assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure
Measured: 48 hours
To evaluate the effects of 48 hours treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patient global assessment (PGA), change in NT-proBNP, incidence of worsening heart failure, and short term clinical outcomes
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytokinetics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300013
- Sponsor's protocol ID
- 20100754
- Status last verified
- Jul 2021
- First submitted
- 17 Feb 2011
- Last updated
- 27 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Teerlink JR, Felker GM, McMurray JJV, Ponikowski P, Metra M, Filippatos GS, Ezekowitz JA, Dickstein K, Cleland JGF, Kim JB, Lei L, Knusel B, Wolff AA, Malik FI, Wasserman SM; ATOMIC-AHF Investigators. Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1444-1455. doi: 10.1016/j.jacc.2016.01.031.
PubMed 27012405
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 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 Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure
- ClinicalTrials.gov ID
- NCT01300013
- Acronym / sponsor ID
- 20100754
- Conditions
- Heart Failure
- Keywords
- Intravenous, IV, Left Ventricular Systolic Dysfunction, Hospitalized, Acute heart failure, Heart failure, Left ventricular ejection fraction, pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- CytokineticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 21 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized, double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to omecamtiv mecarbil or placebo.
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.
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 |
|---|---|---|
| Omecamtiv mecarbil | Experimental | Drug: Omecamtiv mecarbil |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female 18 - 85 years
- Hospitalized for worsening heart failure, within 24 hours of initiating IV loop diuretic
- Dyspnea due to heart failure, at rest or with minimal exertion
- History of left ventricular ejection fraction (LVEF) ≤ 40%
- Elevated brain natriuretic peptide (BNP) or N-terminal fragment BNP (NT-proBNP)
Key exclusion criteria (5 listed)
- Receiving IV vasopressor (excluding low dopamine), inotropic or mechanical support
- Acute coronary syndrome (ACS)
- Within 30 days prior to enrollment: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, ACS, coronary revascularization, transient ischemic attack (TIA) or stroke, sustained ventricular arrhythmia, or major surgery
- Severe valvular stenosis, hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
- Estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2
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 |
|---|---|---|
| Placebo48-hour infusion of placebo | Drug | Placebo |
| Omecamtiv mecarbilAlso: CK-1827452, AMG 42348-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment. | Drug | Omecamtiv mecarbil |
Primary outcome
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure.
Time frame: 48 hours
3 secondary outcomes
To characterize pharmacokinetics of omecamtiv mecarbil including metabolites following IV infusion and to evaluate the relationship between omecamtiv mecarbil plasma concentration and echocardiographic parameters in subjects with AHF
Time frame: 48 hours
To assess the safety and tolerability of 3 dose levels of IV omecamtiv mecarbil compared with placebo in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure
Time frame: 48 hours
To evaluate the effects of 48 hours treatment with IV omecamtiv mecarbil on additional measures of dyspnea, patient global assessment (PGA), change in NT-proBNP, incidence of worsening heart failure, and short term clinical outcomes
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2021.
- Derived from this study: PubMed 27012405Teerlink JR, Felker GM, McMurray JJV, Ponikowski P, Metra M, Filippatos GS, Ezekowitz JA, Dickstein K, Cleland JGF, Kim JB, Lei L, Knusel B, Wolff AA, Malik FI, Wasserman SM; ATOMIC-AHF Investigators. Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study. J Am Coll Cardiol. 2016 Mar 29;67(12):1444-1455. doi: 10.1016/j.jacc.2016.01.031.
- 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
150 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omecamtiv mecarbil in people with Heart Failure, run by Cytokinetics at 150 sites in 19 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 5 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 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 150 sites in United States, Germany, Russia, Canada, Bulgaria and 14 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV) omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure. (time frame: 48 hours). 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 NCT01300013, which also lists 1 linked publication.
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 27 Jul 2021.