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)
NCT ID: NCT01300013
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
614 participants
INTERVENTIONAL
2011-04-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Omecamtiv mecarbil
Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Placebo
Placebo
48-hour infusion of placebo
Interventions
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Placebo
48-hour infusion of placebo
Omecamtiv mecarbil
48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Mobile, Alabama, United States
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Inglewood, California, United States
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La Jolla, California, United States
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San Francisco, California, United States
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Danbury, Connecticut, United States
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Newark, Delaware, United States
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Atlantis, Florida, United States
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Clearwater, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Detroit, Michigan, United States
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Novi, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Newark, New Jersey, United States
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Cortlandt Manor, New York, United States
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Roslyn, New York, United States
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The Bronx, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Fairfield, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Nashville, Tennessee, United States
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Tullahoma, Tennessee, United States
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Houston, Texas, United States
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Murray, Utah, United States
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Darlinghurst, New South Wales, Australia
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Woolloongabba, Queensland, Australia
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Bedford Park, South Australia, Australia
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Prahran, Victoria, Australia
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Richmond, Victoria, Australia
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Aalst, , Belgium
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Bonheiden, , Belgium
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Ghent, , Belgium
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Roeselare, , Belgium
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Blagoevgrad, , Bulgaria
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Kazanlak, , Bulgaria
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Pazardzhik, , Bulgaria
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Plovdiv, , Bulgaria
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Sandanski, , Bulgaria
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Smolyan, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Brno, , Czechia
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Brno, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Ústí nad Labem, , Czechia
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Helsinki, , Finland
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Turku, , Finland
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Caen, , France
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Lille, , France
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Montpellier, , France
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Paris, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Bad Nauheim, , Germany
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Dortmund, , Germany
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Dresden, , Germany
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Frankfurt, , Germany
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Frankfurt, , Germany
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Greifswald, , Germany
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Halle, , Germany
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Hamburg, , Germany
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Homburg, , Germany
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Langen, , Germany
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Regensburg, , Germany
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Stuttgart, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Athens, , Greece
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Haidari, , Greece
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Heraklion, , Greece
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Pátrai, , Greece
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Pécs, , Hungary
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Szolnok, , Hungary
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Brescia, , Italy
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Cagliari, , Italy
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Pavia, , Italy
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Udine, , Italy
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Kaunas, , Lithuania
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Vilnius, , Lithuania
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Delft, , Netherlands
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Deventer, , Netherlands
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Utrecht, , Netherlands
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Oslo, , Norway
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Stavanger, , Norway
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Bialystok, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Wroclaw, , Poland
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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St.-Petrsburg, , Russia
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Bratislava, , Slovakia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Bristol, , United Kingdom
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Cottingham, , United Kingdom
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Glasgow, , United Kingdom
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Harrow, , United Kingdom
Countries
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References
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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.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20100754
Identifier Type: -
Identifier Source: org_study_id
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