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 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
1 other identifier
interventional
614
19 countries
150
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 heart-failure
Started Apr 2011
Typical duration for phase_2 heart-failure
150 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2011
CompletedFirst Posted
Study publicly available on registry
February 21, 2011
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJuly 27, 2021
July 1, 2021
2 years
February 17, 2011
July 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
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
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
48 hours
Study Arms (2)
Omecamtiv mecarbil
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cytokineticslead
Study Sites (150)
Research Site
Mobile, Alabama, 36608, United States
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Inglewood, California, 90301, United States
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La Jolla, California, 92037, United States
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San Francisco, California, 94121, United States
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Danbury, Connecticut, 06810, United States
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Newark, Delaware, 19718, United States
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Atlantis, Florida, 33462, United States
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Clearwater, Florida, 33756, United States
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Fort Lauderdale, Florida, 33308, United States
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Miami, Florida, 33133, United States
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Orlando, Florida, 32803, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Peoria, Illinois, 61636, United States
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Baltimore, Maryland, 21201, United States
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Detroit, Michigan, 48201, United States
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Detroit, Michigan, 48202, United States
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Novi, Michigan, 48374, United States
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Minneapolis, Minnesota, 55417, United States
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St Louis, Missouri, 63110, United States
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Lincoln, Nebraska, 68506, United States
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Newark, New Jersey, 07103, United States
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Cortlandt Manor, New York, 10567, United States
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Roslyn, New York, 11576, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599, United States
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Charlotte, North Carolina, 28204, United States
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Durham, North Carolina, 27705, United States
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Winston-Salem, North Carolina, 27103, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45220, United States
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Cincinnati, Ohio, 45267, United States
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Cleveland, Ohio, 44109, United States
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Columbus, Ohio, 43210, United States
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Fairfield, Ohio, 45014, United States
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Oklahoma City, Oklahoma, 73120, United States
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Portland, Oregon, 97239, United States
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Charleston, South Carolina, 29425, United States
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Greenville, South Carolina, 29605, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232-8802, United States
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Tullahoma, Tennessee, 37388, United States
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Houston, Texas, 77030, United States
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Murray, Utah, 84107, United States
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Darlinghurst, New South Wales, 2010, Australia
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Woolloongabba, Queensland, 4102, Australia
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Bedford Park, South Australia, 5042, Australia
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Prahran, Victoria, 3181, Australia
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Richmond, Victoria, 3121, Australia
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Aalst, 9300, Belgium
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Bonheiden, 2820, Belgium
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Ghent, 9000, Belgium
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Roeselare, 8800, Belgium
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Blagoevgrad, 2700, Bulgaria
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Kazanlak, 6100, Bulgaria
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Pazardzhik, 4700, Bulgaria
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Plovdiv, 4002, Bulgaria
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Sandanski, 2800, Bulgaria
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Smolyan, 4400, Bulgaria
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Sofia, 1309, Bulgaria
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Sofia, 1431, Bulgaria
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Sofia, 1527, Bulgaria
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Calgary, Alberta, T2N 4Z6, Canada
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Edmonton, Alberta, T6G 2B7, Canada
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Edmonton, Alberta, T6L 5X8, Canada
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Halifax, Nova Scotia, B3H 3A7, Canada
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Ottawa, Ontario, K1Y 4W7, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Québec, Quebec, G1V 4G5, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Brno, 625 00, Czechia
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Brno, 656 91, Czechia
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Prague, 128 08, Czechia
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Prague, 150 06, Czechia
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Ústí nad Labem, 401 13, Czechia
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Helsinki, 00029, Finland
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Turku, 20521, Finland
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Caen, 14033, France
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Lille, 59037, France
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Montpellier, 34295, France
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Paris, 75010, France
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Paris, 75651, France
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Strasbourg, 67091, France
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Toulouse, 31403, France
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Bad Nauheim, 61231, Germany
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Dortmund, 44137, Germany
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Dresden, 01307, Germany
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Frankfurt, 60488, Germany
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Frankfurt, 60590, Germany
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Greifswald, 17475, Germany
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Halle, 06097, Germany
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Hamburg, 20246, Germany
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Homburg, 66421, Germany
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Langen, 63225, Germany
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Regensburg, 93053, Germany
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Stuttgart, 70376, Germany
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Würzburg, 97080, Germany
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Athens, 11528, Greece
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Athens, 16673, Greece
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Haidari, 12462, Greece
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Heraklion, 71110, Greece
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Pátrai, 26500, Greece
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Budapest, 1023, Hungary
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Budapest, 1122, Hungary
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Budapest, 1125, Hungary
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Budapest, 1134, Hungary
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Pécs, 7624, Hungary
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Szolnok, 5004, Hungary
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Brescia, 25125, Italy
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Cagliari, 09134, Italy
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Pavia, 27100, Italy
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Udine, 33100, Italy
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Kaunas, 50009, Lithuania
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Vilnius, 08661, Lithuania
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Delft, 2625 AD, Netherlands
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Deventer, 7416 SE, Netherlands
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Utrecht, 3584 CX, Netherlands
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Oslo, 0424, Norway
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Stavanger, 4011, Norway
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Bialystok, 15-276, Poland
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Gdansk, 80-952, Poland
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Krakow, 31-202, Poland
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Krakow, 31-501, Poland
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Lodz, 91-347, Poland
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Lublin, 20-954, Poland
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Wroclaw, 50-981, Poland
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Moscow, 109240, Russia
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Moscow, 111539, Russia
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Moscow, 115093, Russia
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Moscow, 117292, Russia
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Moscow, 119620, Russia
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Moscow, 119991, Russia
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Moscow, 127299, Russia
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Moscow, 127473, Russia
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Saint Petersburg, 195067, Russia
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Saint Petersburg, 197341, Russia
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Saint Petersburg, 198205, Russia
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Saint Petersburg, 199106, Russia
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St.-Petrsburg, 196247, Russia
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Bratislava, 826 06, Slovakia
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Bratislava, 851 07, Slovakia
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Košice, 040 66, Slovakia
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Nitra, 949 01, Slovakia
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Bristol, BS2 8HW, United Kingdom
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Cottingham, HU16 5JQ, United Kingdom
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Glasgow, G11 6NT, United Kingdom
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Harrow, HA1 3UJ, United Kingdom
Related Publications (1)
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.
PMID: 27012405DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2011
First Posted
February 21, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2013
Study Completion
September 1, 2013
Last Updated
July 27, 2021
Record last verified: 2021-07