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)
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | April 2011 |
| End Date: | March 2014 |
| Contact: | Amgen Call Center |
| Phone: | 866-572-6436 |
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
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.
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
We found this trial at
22
sites
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