COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure

Completed · Phase 2 · Has a placebo group

Conditions studied: Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure, Left Ventricular Ejection Fraction, Pharmacokinetics, Echocardiogram

In brief

The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic dysfunction and (ii) to characterize its pharmacokinetics (PK) over 20 weeks of treatment.

Key facts

Study ID

NCT01786512

Run by

Cytokinetics

People needed

544

Starts

2013-02-26

Expected to finish

2015-08-19

Last updated by the study team

2021-08-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of chronic heart failure (HF), defined as requiring treatment for HF for a minimum of 4 weeks prior to screening
• Treated with stable, optimal pharmacological therapy for ≥ 4 weeks
• History of left ventricular ejection fraction (LVEF) ≤ 40%
• Elevated N-terminal prohormone B-type natriuretic peptide (NT-proBNP)

You may not qualify if…

• Severe uncorrected valvular heart disease
• Hospitalization within 30 days prior to enrollment
• Hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease
• Acute myocardial infarction, unstable angina or persistent angina at rest within 30 days prior to randomization
• Systolic blood pressure > 160 mmHg or < 90 mmHg or diastolic blood pressure > 90 mmHg
• Total bilirubin ≥ 2 x upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 3 x ULN
• Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m\^2

Where it is running

• Research Site — Costa Mesa, California, United States
• Research Site — Fresno, California, United States
• Research Site — Inglewood, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Thousand Oaks, California, United States
• Research Site — Tustin, California, United States
• Research Site — Danbury, Connecticut, United States
• Research Site — Newark, Delaware, United States
• Research Site — Atlantis, Florida, United States
• Research Site — Aventura, Florida, United States
• Research Site — Clearwater, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Macon, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — Auburn, Maine, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Detroit, Michigan, United States
• Research Site — Petoskey, Michigan, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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