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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This Phase 2 study tests doses of CK-4021586 to learn about its safety and how well people tolerate it. It is for adults ages 40 to 85 with symptoms of HFpEF, a type of heart failure where the heart’s pumping strength is preserved.
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 40 to 85 years old at screening.
- Have heart failure in NYHA class II or III, meaning symptoms limit physical activity.
- Have a heart ultrasound showing that the heart pumps out at least 60% of the blood in its main pumping chamber with each beat.
- Have an NT-proBNP blood test, which measures heart strain, of at least 300 pg/mL with a normal heart rhythm, or at least 900 pg/mL with atrial fibrillation or flutter (types of irregular heartbeat).
- Have a body mass index (BMI), a measure based on height and weight, below 40.
- If taking a beta-blocker, ACE inhibitor, ARB, or ARNI heart medicine, have no dose changes for more than 30 days before screening.
- If taking a GLP-1 medicine, have no dose changes for more than 24 weeks before screening and no planned dose changes during the study.
Who can't join
- Have another serious health problem, cancer, or active infection that the study doctor or medical monitor believes could make the study unsafe or affect study tests, procedures, or completion.
- Other study rules for who can and cannot join also apply.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (26)
AL
- Eastern Shore Research Institute, LLC · Fairhope, AL 36532More trials in Fairhope
AR
- John L. McClellan Memorial Veterans Hospital · Little Rock, AR 72205More trials in Little Rock
AZ
- University of Arizona Sarver Heart Center · Tucson, AZ 85724More trials in Tucson
CA
- BioSolutions Clinical Research Center · Imperial, CA 92251More trials in Imperial
- Profound Research LLC · Pasadena, CA 91105More trials in Pasadena
- University of California, San Francisco - Heart and Vascular Center · San Francisco, CA 94143More trials in San Francisco
- FOMAT - Comprehensive Cardiovascular Care · Santa Maria, CA 93454More trials in Santa Maria
- Blue Coast Research Center, LLC · Vista, CA 92081More trials in Vista
FL
- Las Mercedes Medical Research · Hialeah, FL 33012More trials in Hialeah
- New Generation of Medical Research · Hialeah, FL 33016More trials in Hialeah
- Cleveland Clinic Florida · Weston, FL 33331More trials in Weston
IL
- Methodist Medical Center of Illinois · Peoria, IL 61636More trials in Peoria
LA
- Louisiana Heart Center · Slidell, LA 70458More trials in Slidell
MA
- Massachusetts General Hospital · Boston, MA 02214More trials in Boston
MN
- Mayo Clinic · Rochester, MN 55905More trials in Rochester
MO
- Washington University Center for Advanced Medicine · St Louis, MO 63110More trials in St Louis
NJ
- Morristown Medical Center · Morristown, NJ 07960More trials in Morristown
NY
- NYU Langone Health · New York, NY 10016More trials in New York
- Mount Sinai West · New York, NY 10019More trials in New York
OH
- The Lindner Center for Research & Education at The Christ Hospital · Cincinnati, OH 45219More trials in Cincinnati
OR
- Oregon Health and Science University · Portland, OR 97239More trials in Portland
TX
- University of Texas Southwestern Medical Center, Dallas · Dallas, TX 75390More trials in Dallas
- Center for Advanced Heart Failure · Houston, TX 77030More trials in Houston
VA
- DelRicht Research · Vienna, VA 22182More trials in Vienna
WA
- Swedish Heart & Vascular Institute, Advanced Cardiac Support Program · Seattle, WA 98122More trials in Seattle
WI
- Froedtert Hospital - Center for Advanced Care · Milwaukee, WI 53226More trials in Milwaukee