AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Cytokinetics · NCT06793371
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40–85 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 2
- Target enrollment
- 60
- US sites recruiting
- 24
- Study start
- February 6, 2025
- Record last updated
- August 27, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Being studied: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg); Placebo to match CK-4021586
Conditions: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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 Criteria
- 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.
Recruiting US locations
Eastern Shore Research Institute, LLC
Fairhope, AL 36532
University of Arizona Sarver Heart Center
Tucson, AZ 85724
John L. McClellan Memorial Veterans Hospital
Little Rock, AR 72205
BioSolutions Clinical Research Center
Imperial, CA 92251
Profound Research LLC
Pasadena, CA 91105
University of California, San Francisco - Heart and Vascular Center
San Francisco, CA 94143
FOMAT - Comprehensive Cardiovascular Care
Santa Maria, CA 93454
Blue Coast Research Center, LLC
Vista, CA 92081
Las Mercedes Medical Research
Hialeah, FL 33012
New Generation of Medical Research
Hialeah, FL 33016
Cleveland Clinic Florida
Weston, FL 33331
Methodist Medical Center of Illinois
Peoria, IL 61636
Massachusetts General Hospital
Boston, MA 02214
Mayo Clinic
Rochester, MN 55905
Washington University Center for Advanced Medicine
St Louis, MO 63110
Morristown Medical Center
Morristown, NJ 07960
NYU Langone Health
New York, NY 10016
Mount Sinai West
New York, NY 10019
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, OH 45219
Oregon Health and Science University
Portland, OR 97239
University of Texas Southwestern Medical Center, Dallas
Dallas, TX 75390
Center for Advanced Heart Failure
Houston, TX 77030
Swedish Heart & Vascular Institute, Advanced Cardiac Support Program
Seattle, WA 98122
Froedtert Hospital - Center for Advanced Care
Milwaukee, WI 53226
Study contacts (from the official record)
- Cytokinetics MD · 650-624-2929 · medicalaffairs@cytokinetics.com
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