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)
Completed · Phase 2 · Has a placebo group
Conditions studied: Heart Failure
In brief
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.
Key facts
- Study ID
- NCT01300013
- Run by
- Cytokinetics
- People needed
- 614
- Starts
- 2011-04-01
- Expected to finish
- 2013-09-01
- Last updated by the study team
- 2021-07-27
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Research Site — Inglewood, California, United States
- Research Site — La Jolla, California, United States
- Research Site — San Francisco, California, United States
- Research Site — Danbury, Connecticut, United States
- Research Site — Newark, Delaware, United States
- Research Site — Atlantis, Florida, United States
- Research Site — Clearwater, Florida, United States
- Research Site — Fort Lauderdale, Florida, United States
- Research Site — Miami, Florida, United States
- Research Site — Orlando, Florida, United States
- Research Site — Atlanta, Georgia, United States
- Research Site — Chicago, Illinois, United States
- Research Site — Peoria, Illinois, United States
- Research Site — Baltimore, Maryland, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Detroit, Michigan, United States
- Research Site — Novi, Michigan, United States
- Research Site — Minneapolis, Minnesota, United States
- Research Site — St Louis, Missouri, United States
- Research Site — Lincoln, Nebraska, United States
- Research Site — Newark, New Jersey, United States
- Research Site — Cortlandt Manor, New York, United States
- Research Site — Roslyn, New York, United States
- Research Site — The Bronx, New York, United States
- Research Site — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.