Tests CK-4021586 in adults with heart failure and preserved ejection fraction
Tests different doses of CK-4021586 against placebo in adults with heart failure.
Plain-language title generated from the registry record
Registry title: AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Key facts
- Where
- Boston, Cincinnati, Dallas, Fairhope, Hialeah, Houston, Imperial, Little Rock, Milwaukee, Morristown, New York, Pasadena, Peoria, Portland, Rochester, San Francisco, Santa Maria, Seattle, Slidell, St Louis, Tucson, Vienna, Vista, and Weston, United StatesSee the 26 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 40 and 85 years old?
Source: NCT06793371, who can take part
Where in United States
- Massachusetts General HospitalBoston, United StatesTaking people
- The Lindner Center for Research & Education at The Christ HospitalCincinnati, United StatesTaking people
- University of Texas Southwestern Medical Center - DallasDallas, United StatesTaking people
- Eastern Shore Research Institute, LLCFairhope, United StatesTaking people
- Las Mercedes Medical ResearchHialeah, United StatesTaking people
- New Generation of Medical ResearchHialeah, United StatesTaking people
- Center for Advanced Heart FailureHouston, United StatesTaking people
- BioSolutions Clinical Research CenterImperial, United StatesTaking people
- John L McClellan Memorial Veterans HospitalLittle Rock, United StatesTaking people
- Froedtert Hospital - Center for Advanced CareMilwaukee, United StatesTaking people
- Morristown Medical CenterMorristown, United StatesTaking people
- Mount Sinai WestNew York, United StatesTaking people
- NYU Langone HealthNew York, United StatesTaking people
- Profound Research LLCPasadena, United StatesTaking people
- Methodist Medical Center of IllinoisPeoria, United StatesTaking people
- Oregon Health and Science UniversityPortland, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- University of California, San Francisco - Heart and Vascular CenterSan Francisco, United StatesTaking people
- FOMAT - Comprehensive Cardiovascular CareSanta Maria, United StatesTaking people
- Swedish Heart & Vascular Institute, Advanced Cardiac Support ProgramSeattle, United StatesTaking people
- Louisiana Heart CenterSlidell, United StatesNo longer taking part
- Washington University Center for Advanced MedicineSt Louis, United StatesTaking people
- University of Arizona Sarver Heart CenterTucson, United StatesTaking people
- DelRicht ResearchVienna, United StatesNo longer taking part
- Blue Coast Research Center LLCVista, United StatesTaking people
- Cleveland Clinic FloridaWeston, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cytokinetics
- Trial code
- NCT06793371EU 2024-516349-38-00
- Record updated
- 27 August 2026
- Original description
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.Read full original descriptionShow less
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
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Inclusion: 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; 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.
Exclusion: History or evidence of any other clinically significant disorder, malignancy, active infection, other condition, or disease that, in the opinion of the investigator or the Medical Monitor, would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion; Other protocol-defined Inclusion/Exclusion criteria apply.