NCT06793371 · Cytokinetics
AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
(AMBER-HFpEF)
What this study is about
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
View original scientific description
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
Interventions
DRUG
CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
CK-4021586 administered orally
DRUG
Placebo to match CK-4021586
Placebo administered orally
Primary outcome measures
Incidence of early drug discontinuation
Time frame: 12 weeks
Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF
Incidence of LVEF < 40%
Time frame: 12 weeks
Incidence of left-ventricular ejection fraction (LVEF) \< 40% observed during dosing of CK-4021586 in patients with HFpEF
Incidence of AEs
Time frame: 12 weeks
Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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), or sodium-glucose contransporter-2 (SGLT2)-inhibitors must be on stable doses for more than 4 weeks 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 opi
Where
- Fairhope, Alabama
- Tucson, Arizona
- Little Rock, Arkansas
- Imperial, California
- Pasadena, California
- San Francisco, California
- Santa Maria, California
- Vista, California
- Hialeah, Florida
- Weston, Florida
- Peoria, Illinois
- Slidell, Louisiana
And 12 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 29, 2026 · Source of record for eligibility and locations