AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Recruiting · NCT06793371 · Interventional (participants receive a specific treatment) · Lead sponsor: Cytokinetics
View the official record on ClinicalTrials.gov →Interventions studied
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)Placebo to match CK-4021586
What this trial is about
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
26 locations listed across 18 US states.
- Eastern Shore Research Institute, LLC - Fairhope, Alabama, United States
- University of Arizona Sarver Heart Center - Tucson, Arizona, United States
- John L. McClellan Memorial Veterans Hospital - Little Rock, Arkansas, United States
- BioSolutions Clinical Research Center - Imperial, California, United States
- Profound Research LLC - Pasadena, California, United States
- University of California, San Francisco - Heart and Vascular Center - San Francisco, California, United States
- FOMAT - Comprehensive Cardiovascular Care - Santa Maria, California, United States
- Blue Coast Research Center, LLC - Vista, California, United States
- Las Mercedes Medical Research - Hialeah, Florida, United States
- New Generation of Medical Research - Hialeah, Florida, United States
- Cleveland Clinic Florida - Weston, Florida, United States
- Methodist Medical Center of Illinois - Peoria, Illinois, United States
- Louisiana Heart Center - Slidell, Louisiana, United States
- Massachusetts General Hospital - Boston, Massachusetts, United States
- Mayo Clinic - Rochester, Minnesota, United States
- Washington University Center for Advanced Medicine - St Louis, Missouri, United States
- Morristown Medical Center - Morristown, New Jersey, United States
- NYU Langone Health - New York, New York, United States
- Mount Sinai West - New York, New York, United States
- The Lindner Center for Research & Education at The Christ Hospital - Cincinnati, Ohio, United States
- Oregon Health and Science University - Portland, Oregon, United States
- University of Texas Southwestern Medical Center, Dallas - Dallas, Texas, United States
- Center for Advanced Heart Failure - Houston, Texas, United States
- DelRicht Research - Vienna, Virginia, United States
- Swedish Heart & Vascular Institute, Advanced Cardiac Support Program - Seattle, Washington, United States
- Froedtert Hospital - Center for Advanced Care - Milwaukee, Wisconsin, United States