Heart Failure Clinical Trial
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)
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
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There are 150 Locations for this study
Mobile Alabama, 36608, United States
Inglewood California, 90301, United States
La Jolla California, 92037, United States
San Francisco California, 94121, United States
Danbury Connecticut, 06810, United States
Newark Delaware, 19718, United States
Atlantis Florida, 33462, United States
Clearwater Florida, 33756, United States
Fort Lauderdale Florida, 33308, United States
Miami Florida, 33133, United States
Orlando Florida, 32803, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Peoria Illinois, 61636, United States
Baltimore Maryland, 21201, United States
Detroit Michigan, 48201, United States
Detroit Michigan, 48202, United States
Novi Michigan, 48374, United States
Minneapolis Minnesota, 55417, United States
Saint Louis Missouri, 63110, United States
Lincoln Nebraska, 68506, United States
Newark New Jersey, 07103, United States
Bronx New York, 10467, United States
Cortlandt Manor New York, 10567, United States
Roslyn New York, 11576, United States
Chapel Hill North Carolina, 27599, United States
Charlotte North Carolina, 28204, United States
Durham North Carolina, 27705, United States
Winston-Salem North Carolina, 27103, United States
Cincinnati Ohio, 45219, United States
Cincinnati Ohio, 45220, United States
Cincinnati Ohio, 45267, United States
Cleveland Ohio, 44109, United States
Columbus Ohio, 43210, United States
Fairfield Ohio, 45014, United States
Oklahoma City Oklahoma, 73120, United States
Portland Oregon, 97239, United States
Charleston South Carolina, 29425, United States
Greenville South Carolina, 29605, United States
Memphis Tennessee, 38120, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Tullahoma Tennessee, 37388, United States
Houston Texas, 77030, United States
Murray Utah, 84107, United States
Darlinghurst New South Wales, 2010, Australia
Woolloongabba Queensland, 4102, Australia
Bedford Park South Australia, 5042, Australia
Prahran Victoria, 3181, Australia
Richmond Victoria, 3121, Australia
Aalst , 9300, Belgium
Bonheiden , 2820, Belgium
Gent , 9000, Belgium
Roeselare , 8800, Belgium
Blagoevgrad , 2700, Bulgaria
Kazanlak , 6100, Bulgaria
Pazardzhik , 4700, Bulgaria
Plovdiv , 4002, Bulgaria
Sandanski , 2800, Bulgaria
Smolyan , 4400, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1527, Bulgaria
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Edmonton Alberta, T6L 5, Canada
Halifax Nova Scotia, B3H 3, Canada
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M5B 1, Canada
Toronto Ontario, M5G 1, Canada
Montreal Quebec, H3G 1, Canada
Québec Quebec, G1V 4, Canada
Sherbrooke Quebec, J1H 5, Canada
Brno , 625 0, Czechia
Brno , 656 9, Czechia
Praha 2 , 128 0, Czechia
Praha 5 , 150 0, Czechia
Usti nad Labem , 401 1, Czechia
Helsinki , 00029, Finland
Turku , 20521, Finland
Caen Cedex 9 , 14033, France
Lille Cedex , 59037, France
Montpellier cedex 05 , 34295, France
Paris Cedex 13 , 75651, France
Paris , 75010, France
Strasbourg , 67091, France
Toulouse Cedex 09 , 31403, France
Bad Nauheim , 61231, Germany
Dortmund , 44137, Germany
Dresden , 01307, Germany
Frankfurt , 60488, Germany
Frankfurt , 60590, Germany
Greifswald , 17475, Germany
Halle/Saale , 06097, Germany
Hamburg , 20246, Germany
Homburg , 66421, Germany
Langen , 63225, Germany
Regensburg , 93053, Germany
Stuttgart , 70376, Germany
Würzburg , 97080, Germany
Athens , 11528, Greece
Athens , 16673, Greece
Haidari , 12462, Greece
Heraklion , 71110, Greece
Patra , 26500, Greece
Budapest , 1023, Hungary
Budapest , 1122, Hungary
Budapest , 1125, Hungary
Budapest , 1134, Hungary
Pecs , 7624, Hungary
Szolnok , 5004, Hungary
Brescia , 25125, Italy
Cagliari , 09134, Italy
Pavia , 27100, Italy
Udine , 33100, Italy
Kaunas , 50009, Lithuania
Vilnius , 08661, Lithuania
Delft , 2625 , Netherlands
Deventer , 7416 , Netherlands
Utrecht , 3584 , Netherlands
Oslo , 0424, Norway
Stavanger , 4011, Norway
Bialystok , 15-27, Poland
Gdansk , 80-95, Poland
Krakow , 31-20, Poland
Krakow , 31-50, Poland
Lodz , 91-34, Poland
Lublin , 20-95, Poland
Wroclaw , 50-98, Poland
Moscow , 10924, Russian Federation
Moscow , 11153, Russian Federation
Moscow , 11509, Russian Federation
Moscow , 11729, Russian Federation
Moscow , 11962, Russian Federation
Moscow , 11999, Russian Federation
Moscow , 12729, Russian Federation
Moscow , 12747, Russian Federation
Saint Petersburg , 19734, Russian Federation
Saint-Petersburg , 19506, Russian Federation
St Petersburg , 19820, Russian Federation
St. Petersburg , 19910, Russian Federation
St.-Petrsburg , 19624, Russian Federation
Bratislava , 826 0, Slovakia
Bratislava , 851 0, Slovakia
Kosice , 040 6, Slovakia
Nitra , 949 0, Slovakia
Bristol , BS2 8, United Kingdom
Cottingham , HU16 , United Kingdom
Glasgow , G11 6, United Kingdom
Harrow , HA1 3, United Kingdom
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