Trial Information

ATOMIC-HF - 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. The primary hypothesis is that at least 1 dose level of omecamtiv mecarbil IV will be well tolerated and will result in improvement of dyspnea in subjects with left ventricular systolic dysfunction hospitalized for acute heart failure

Patient Inclusion Criteria:

Subject or legally acceptable representative informed consent provided
Male or female = 18 years of age at the time of randomization
Current hospitalization for a primary reason of worsening heart failure (determined by the investigator) and requiring IV therapy for heart failure
History of chronic heart failure (defined as requiring treatment for heart failure for a minimum of 30 days before hospitalization)
History of left-ventricular ejection fraction (LVEF) = 35% (echocardiogram, radionuclide ventriculography, cardiac magnetic resonance imaging, or contrast ventriculography) within 12 months before randomization without a subsequent intervening value of > 35%
Dyspnea at rest due to heart failure at least 2 hours after having received = 40 mg intravenous furosemide (or equivalent dose of an alternative loop diuretic); dyspnea should be present at randomization
Brain-type natriuretic peptide (BNP) = 400 pg/mL or NT-proBNP = 1600 pg/mL during screening (BNP = 600 pg/mL or NT-proBNP = 2400 pg/mL if the subject has atrial fibrillation at presentation)
If participating in the PK/PD substudy, subject must currently be in sinus rhythm.

Patient Inclusion Criteria:
Various heart failure and other cardiovascular exclusions apply, including, but not limited to, receiving IV vasopressor (excluding dopamine = 5 mcg/kg/min), inotropic or mechanical circulatory (eg, intra-aortic balloon pump counterpulsation) support between admission and randomization, a pulmonary artery catheter, endotracheal mechanical ventilation, evolving acute coronary syndrome, or within 6 weeks prior to enrollment any of the following: cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation, hospitalization for acute coronary syndrome, coronary revascularization, transient ischemic attack or stroke, sustained ventricular arrhythmia, or major surgery. (AND OTHERS)

Joshua Larned, MD, Clinical Research Coordinator
Holy Cross Jim Moran Heart and Vascular Research Institute
1951 NE 47th Street
Fort Lauderdale, FL 33308
Phone: (954) 229-8400
Fax: (954) 229-8597
Email: cheryl.langer@holy-cross.com

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Research Center Information: Holy Cross Jim Moran Heart and Vascular Research Institute

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