COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
Launched by CYTOKINETICS · Feb 6, 2013
Trial Information
Current as of June 06, 2025
Completed
Keywords
ClinConnect Summary
Omecamtiv mecarbil (AMG 423, CK-1827452) is a novel small molecule that increases cardiac contractility by selectively and directly activating the enzymatic domain of cardiac myosin heavy chain, the force-generating motor protein of the cardiac sarcomere. This is a randomized, placebo-controlled, multicenter, phase 2 study, consisting of a dose escalation phase to select 1 of 3 omecamtiv mecarbil oral formulations in 2 dose escalation cohorts, followed by an expansion phase to evaluate 20 weeks of administration of the selected omecamtiv mecarbil formulation at 2 target dose levels, compare...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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)
- Exclusion criteria:
- • 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
About Cytokinetics
Cytokinetics is a biopharmaceutical company dedicated to the discovery and development of innovative muscle-activating therapies to treat serious diseases and medical conditions characterized by muscle weakness and dysfunction. By leveraging its expertise in muscle biology and drug development, Cytokinetics aims to advance novel therapeutics for conditions such as heart failure, amyotrophic lateral sclerosis (ALS), and other neuromuscular disorders. The company is committed to scientific excellence and collaboration, working closely with academic institutions and industry partners to bring meaningful treatments to patients in need.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Houston, Texas, United States
Nashville, Tennessee, United States
Chapel Hill, North Carolina, United States
Detroit, Michigan, United States
Gent, , Belgium
Praha 2, , Czechia
Liverpool, , United Kingdom
Los Angeles, California, United States
Madison, Wisconsin, United States
Nedlands, Western Australia, Australia
Costa Mesa, California, United States
Detroit, Michigan, United States
Portland, Oregon, United States
Las Vegas, Nevada, United States
Bronx, New York, United States
Antwerpen, , Belgium
Liege, , Belgium
Krakow, , Poland
Sofia, , Bulgaria
Dundee, , United Kingdom
Miami, Florida, United States
Lublin, , Poland
Los Angeles, California, United States
Chicago, Illinois, United States
Baltimore, Maryland, United States
Auburn, Maine, United States
Danbury, Connecticut, United States
Mobile, Alabama, United States
La Jolla, California, United States
Petoskey, Michigan, United States
Saint Louis, Missouri, United States
Bronx, New York, United States
Cortlandt Manor, New York, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Nashville, Tennessee, United States
Tullahoma, Tennessee, United States
Seattle, Washington, United States
Bonheiden, , Belgium
Plovdiv, , Bulgaria
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Ottawa, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Berlin, , Germany
Budapest, , Hungary
Zalaegerszeg, , Hungary
Pavia, , Italy
Kaunas, , Lithuania
Vilnius, , Lithuania
Groningen, , Netherlands
Bialystok, , Poland
Krakow, , Poland
Wroclaw, , Poland
Harrow, , United Kingdom
Leicester, , United Kingdom
Greenville, South Carolina, United States
Aventura, Florida, United States
Trois Rivieres, Quebec, Canada
Macon, Georgia, United States
Atlanta, Georgia, United States
Tampa, Florida, United States
Utrecht, , Netherlands
Tampa, Florida, United States
Newark, Delaware, United States
Brno, , Czechia
Clearwater, Florida, United States
Saint Louis, Missouri, United States
Durham, North Carolina, United States
Ieper, , Belgium
Liverpool, , United Kingdom
Verona, , Italy
Glasgow, , United Kingdom
Teplice, , Czechia
Thousand Oaks, California, United States
Las Vegas, Nevada, United States
Tustin, California, United States
Sliven, , Bulgaria
Svitavy, , Czechia
Bad Nauheim, , Germany
Dortmund, , Germany
Amersfoort, , Netherlands
London, , United Kingdom
Inglewood, California, United States
Atlantis, Florida, United States
Darlinghurst, New South Wales, Australia
Kazanlak, , Bulgaria
Pazardzhik, , Bulgaria
Sandanski, , Bulgaria
Smolyan, , Bulgaria
Greifswald, , Germany
Brescia, , Italy
St. Johns, Newfoundland And Labrador, Canada
Praha 4, , Czechia
Wroclaw, , Poland
Macon, Georgia, United States
Verona, , Italy
Miami, Florida, United States
Oklahoma City, Oklahoma, United States
Fresno, California, United States
Winnipeg, Manitoba, Canada
Bad Krozingen, , Germany
Jaszbereny, , Hungary
Québec, Quebec, Canada
London, , United Kingdom
Berlin, , Germany
Budapest, , Hungary
Bialystok, , Poland
Warszawa, , Poland
Minneapolis, Minnesota, United States
Sherbrooke, Quebec, Canada
Olomouc, , Czechia
Klodzko, , Poland
Ruda Slaska, , Poland
Warszawa, , Poland
Dudley, , United Kingdom
Patients applied
Trial Officials
MD
Study Director
Amgen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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