RecruitingPhase 2NCT06793371

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

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

Sponsor

Cytokinetics

Enrollment

60 participants

Start Date

Feb 6, 2025

Study Type

INTERVENTIONAL

Conditions

Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called CK-4021586 in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps with normal force but the muscle is too stiff. The goal is to assess safety and tolerability of the drug. **You may be eligible if...** - You are 40–85 years old with heart failure (NYHA Class II or III) - Your heart pumps normally but is stiff (ejection fraction at least 60%) - Your blood protein marker (NT-proBNP) level meets the study threshold - Your BMI is under 40 - You have been on stable heart medications for at least 30 days **You may NOT be eligible if...** - You have a recent heart attack or unstable heart condition - You have a serious active infection or active cancer - You have significant heart valve disease or other cardiac conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)

CK-4021586 administered orally

DRUGPlacebo to match CK-4021586

Placebo administered orally

Locations(24)

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

View Full Details on ClinicalTrials.gov

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NCT06793371