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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

In brief

This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.

Key facts

Study ID

NCT06793371

Run by

Cytokinetics

People needed

60

Starts

2025-02-06

Expected to finish

2026-09-01

Last updated by the study team

2026-05-29

Who can join

Age: 40 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Froedtert Hospital - Center for Advanced Care — Milwaukee, Wisconsin, United States (enrolling)
• University of Arizona Sarver Heart Center — Tucson, Arizona, United States (enrolling)
• John L. McClellan Memorial Veterans Hospital — Little Rock, Arkansas, United States (enrolling)
• BioSolutions Clinical Research Center — Imperial, California, United States (enrolling)
• Profound Research LLC — Pasadena, California, United States (enrolling)
• University of California, San Francisco - Heart and Vascular Center — San Francisco, California, United States (enrolling)
• FOMAT - Comprehensive Cardiovascular Care — Santa Maria, California, United States (enrolling)
• Blue Coast Research Center, LLC — Vista, California, United States (enrolling)
• New Generation of Medical Research — Hialeah, Florida, United States (enrolling)
• Cleveland Clinic Florida — Weston, Florida, United States (enrolling)
• Methodist Medical Center of Illinois — Peoria, Illinois, United States (enrolling)
• Louisiana Heart Center — Slidell, Louisiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University Center for Advanced Medicine — St Louis, Missouri, United States (enrolling)
• Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
• NYU Langone Health — New York, New York, United States (enrolling)
• Mount Sinai West — New York, New York, United States (enrolling)
• The Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States (enrolling)
• Oregon Health and Science University — Portland, Oregon, United States (enrolling)
• University of Texas Southwestern Medical Center, Dallas — Dallas, Texas, United States (enrolling)
• Center for Advanced Heart Failure — Houston, Texas, United States (enrolling)
• Eastern Shore Research Institute, LLC — Fairhope, Alabama, United States (enrolling)
• Swedish Heart & Vascular Institute, Advanced Cardiac Support Program — Seattle, Washington, United States (enrolling)
• DelRicht Research — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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