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AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Sponsor: Cytokinetics
Summary
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CK-4021586 in Adults With Symptomatic Heart Failure With Preserved Ejection Fraction
Key Details
Gender
All
Age Range
40 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2025-02-06
Completion Date
2026-09
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Placebo to match CK-4021586
Placebo administered orally
Locations (24)
Eastern Shore Research Institute, LLC
Fairhope, Alabama, United States
University of Arizona Sarver Heart Center
Tucson, Arizona, United States
John L. McClellan Memorial Veterans Hospital
Little Rock, Arkansas, United States
BioSolutions Clinical Research Center
Imperial, California, United States
Profound Research LLC
Pasadena, California, United States
University of California, San Francisco - Heart and Vascular Center
San Francisco, California, United States
FOMAT - Comprehensive Cardiovascular Care
Santa Maria, California, United States
Blue Coast Research Center, LLC
Vista, California, United States
New Generation of Medical Research
Hialeah, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Methodist Medical Center of Illinois
Peoria, Illinois, United States
Louisiana Heart Center
Slidell, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University Center for Advanced Medicine
St Louis, Missouri, United States
Morristown Medical Center
Morristown, New Jersey, United States
NYU Langone Health
New York, New York, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
University of Texas Southwestern Medical Center, Dallas
Dallas, Texas, United States
Center for Advanced Heart Failure
Houston, Texas, United States
DelRicht Research
Vienna, Virginia, United States
Swedish Heart & Vascular Institute, Advanced Cardiac Support Program
Seattle, Washington, United States
Froedtert Hospital - Center for Advanced Care
Milwaukee, Wisconsin, United States