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
Cytokinetics
Summary
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Eligibility
- Age range
- 40–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Males and females ≥ 40 years and ≤ 85 years of age at screening. * Diagnosed with HF with NYHA functional class II or III. * Screening echocardiography with LVEF ≥ 60%. * Screening NT-proBNP ≥ 300 pg/mL for participants in sinus rhythm and ≥ 900 pg/mL for participants with comorbid atrial fibrillation or flutter. * Body mass index \< 40 kg/m2. * Participants on beta-blockers, angiotensin-converting enzyme (ACE)/angiotensin II receptor blocker (ARB) or angiotensin receptor/neprilysin inhibitor (ARNI), must be on stable doses for more than 30 days prior to screening. * Par…
Interventions
- DrugCK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
- DrugPlacebo to match CK-4021586
Placebo administered orally
Locations (24)
- Eastern Shore Research Institute, LLCFairhope, Alabama
- University of Arizona Sarver Heart CenterTucson, Arizona
- John L. McClellan Memorial Veterans HospitalLittle Rock, Arkansas
- BioSolutions Clinical Research CenterImperial, California
- Profound Research LLCPasadena, California
- University of California, San Francisco - Heart and Vascular CenterSan Francisco, California