AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
NCT ID: NCT06793371
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2025-02-06
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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CK-4021586 - Cohort 1
Participants may receive 150 mg or 300 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Placebo - Cohort 1
Participants will receive placebo daily for up to 12 weeks.
Placebo to match CK-4021586
Placebo administered orally
CK-4021586 - Cohort 2
Participants may receive 300 mg or 450 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Placebo - Cohort 2
Participants will receive placebo daily for up to 12 weeks.
Placebo to match CK-4021586
Placebo administered orally
CK-4021586 - Cohort 3
Participants may receive 450 mg or 600 mg of CK-4021586 daily, guided by echocardiography assessments, for 12 weeks total.
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Placebo - Cohort 3
Participants will receive placebo daily for up to 12 weeks.
Placebo to match CK-4021586
Placebo administered orally
Interventions
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CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
Placebo to match CK-4021586
Placebo administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
85 Years
ALL
No
Sponsors
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Cytokinetics
INDUSTRY
Responsible Party
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Principal Investigators
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Cytokinetics MD
Role: STUDY_DIRECTOR
Cytokinetics
Locations
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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
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
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
Countries
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Central Contacts
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Other Identifiers
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2024-516349-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
CY 9021
Identifier Type: -
Identifier Source: org_study_id
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