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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: f
View:
• 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), or sodium-glucose contransporter-2 (SGLT2)-inhibitors must be on stable doses for more than 4 weeks prior to screening.
• Participants on a glucagon-like peptide-1 (GLP-1) agonist must be on a stable dose for more than 24 weeks prior to screening with no anticipated plans to change dose during this study.
Locations
United States
Alabama
Eastern Shore Research Institute, LLC
RECRUITING
Fairhope
California
Profound Research LLC
RECRUITING
Pasadena
University of California, San Francisco - Heart and Vascular Center
RECRUITING
San Francisco
Blue Coast Research Center, LLC
RECRUITING
Vista
Florida
New Generation of Medical Research
RECRUITING
Hialeah
Illinois
Methodist Medical Center of Illinois
RECRUITING
Peoria
Louisiana
Louisiana Heart Center
RECRUITING
Slidell
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
Washington University Center for Advanced Medicine
RECRUITING
St Louis
New Jersey
Morristown Medical Center
RECRUITING
Morristown
New York
NYU Langone Health
RECRUITING
New York
Ohio
The Lindner Center for Research & Education at The Christ Hospital
RECRUITING
Cincinnati
Oregon
Oregon Health and Science University
RECRUITING
Portland
Texas
University of Texas Southwestern Medical Center, Dallas
RECRUITING
Dallas
Virginia
DelRicht Research
RECRUITING
Vienna
Washington
Swedish Heart & Vascular Institute, Advanced Cardiac Support Program
RECRUITING
Seattle
Wisconsin
Froedtert Hospital - Center for Advanced Care
RECRUITING
Milwaukee
Contact Information
Primary
Cytokinetics MD
medicalaffairs@cytokinetics.com
650-624-2929
Time Frame
Start Date:2025-02-06
Estimated Completion Date:2026-09
Participants
Target number of participants:60
Treatments
Experimental: CK-4021586 - Cohort 1
Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
Placebo_comparator: Placebo - Cohort 1
Participants will receive placebo daily for up to 12 weeks.
Experimental: CK-4021586 - Cohort 2
Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
Placebo_comparator: Placebo - Cohort 2
Participants will receive placebo daily for up to 12 weeks.
Experimental: CK-4021586 - Cohort 3
Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
Placebo_comparator: Placebo - Cohort 3
Participants will receive placebo daily for up to 12 weeks.