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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

614

Study ID:

NCT01300013

Recruitment Status:

Completed

Sponsor:

Cytokinetics

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There are 150 Locations for this study

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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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Saint 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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Bronx New York, 10467, 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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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, 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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Gent , 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 4, Canada
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Edmonton Alberta, T6G 2, Canada
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Edmonton Alberta, T6L 5, Canada
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Halifax Nova Scotia, B3H 3, Canada
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Ottawa Ontario, K1Y 4, Canada
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Toronto Ontario, M5B 1, Canada
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Toronto Ontario, M5G 1, Canada
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Montreal Quebec, H3G 1, Canada
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Québec Quebec, G1V 4, Canada
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Sherbrooke Quebec, J1H 5, Canada
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Brno , 625 0, Czechia
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Brno , 656 9, Czechia
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Praha 2 , 128 0, Czechia
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Praha 5 , 150 0, Czechia
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Usti nad Labem , 401 1, Czechia
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Helsinki , 00029, Finland
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Turku , 20521, Finland
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Caen Cedex 9 , 14033, France
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Lille Cedex , 59037, France
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Montpellier cedex 05 , 34295, France
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Paris Cedex 13 , 75651, France
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Paris , 75010, France
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Strasbourg , 67091, France
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Toulouse Cedex 09 , 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/Saale , 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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Patra , 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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Pecs , 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 , Netherlands
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Deventer , 7416 , Netherlands
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Utrecht , 3584 , Netherlands
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Oslo , 0424, Norway
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Stavanger , 4011, Norway
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Bialystok , 15-27, Poland
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Gdansk , 80-95, Poland
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Krakow , 31-20, Poland
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Krakow , 31-50, Poland
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Lodz , 91-34, Poland
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Lublin , 20-95, Poland
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Wroclaw , 50-98, Poland
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Moscow , 10924, Russian Federation
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Moscow , 11153, Russian Federation
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Moscow , 11509, Russian Federation
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Moscow , 11729, Russian Federation
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Moscow , 11962, Russian Federation
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Moscow , 11999, Russian Federation
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Moscow , 12729, Russian Federation
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Moscow , 12747, Russian Federation
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Saint Petersburg , 19734, Russian Federation
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Saint-Petersburg , 19506, Russian Federation
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St Petersburg , 19820, Russian Federation
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St. Petersburg , 19910, Russian Federation
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St.-Petrsburg , 19624, Russian Federation
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Bratislava , 826 0, Slovakia
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Bratislava , 851 0, Slovakia
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Kosice , 040 6, Slovakia
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Nitra , 949 0, Slovakia
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Bristol , BS2 8, United Kingdom
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Cottingham , HU16 , United Kingdom
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Glasgow , G11 6, United Kingdom
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Harrow , HA1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

614

Study ID:

NCT01300013

Recruitment Status:

Completed

Sponsor:


Cytokinetics

How clear is this clinincal trial information?

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