Phase 2 Study of CK-4021586 Safety and Tolerability in Adults with Symptomatic Heart Failure with Preserved Ejection Fraction

What this Trial Is About

Researchers are evaluating CK-4021586 in adults aged 40 to 85 years who have symptomatic heart failure with preserved ejection fraction HFpEF. This Phase 2 study aims to find the best dose while assessing safety, tolerability, and how the drug affects heart function and related markers. The study is sponsored by Cytokinetics and involves randomized and blinded comparisons with placebo. Participants may receive various daily doses of CK-4021586150 mg, 300 mg, 450 mg, or 600 mgguided by echocardiography assessments, or a matching placebo, for a total of 12 weeks. The dosing is arranged in cohorts, and participants receive either the drug or placebo during the treatment period while their heart function is closely monitored. During the study, participants will have regular evaluations including echocardiography to measure left ventricular ejection fraction LVEF, blood tests to check NT-proBNP levels, and safety assessments to track adverse events and early drug discontinuation. These measurements occur at baseline, week 6, and week 12. The study monitors pharmacokinetics and pharmacodynamics of CK-4021586 and will follow participants for the full 12-week treatment duration.

AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF