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

Detailed criteria

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

Drug
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Drug
Placebo to match CK-4021586
Placebo administered orally

Locations (26)

Eastern Shore Research Institute, LLC
Fairhope, Alabama
University of Arizona Sarver Heart Center
Tucson, Arizona
John L. McClellan Memorial Veterans Hospital
Little Rock, Arkansas
BioSolutions Clinical Research Center
Imperial, California
Profound Research LLC
Pasadena, California
University of California, San Francisco - Heart and Vascular Center
San Francisco, California