Back to search results

AMBER-HFpEF: CK-4021586 for Symptomatic Heart Failure With Preserved Ejection Fraction

This study, called AMBER-HFpEF, is testing a new drug called CK-4021586 for people with symptomatic heart failure with preserved ejection fraction (HFpEF). HFpEF means your heart can't relax properly to fill with enough blood, even though it pumps blood out well. The study will compare different doses of CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg) to a placebo (an inactive substance) to see how safe and tolerable the drug is. You might be able to join if you are between 40 and 85 years old, have been diagnosed with HFpEF, and meet specific heart function and blood test criteria, including a screening NT-proBNP level. The main goals are to see how many people stop the drug early, how many have a specific change in heart function (LVEF < 40%), and how many experience side effects over 12 weeks. The current recruitment status is unclear.

Study design
This is a Phase 2 dose-finding study involving about 60 participants. It is a multi-center, blinded study, meaning neither you nor your doctor will know if you are receiving CK-4021586 or the placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety and heart function will be monitored for 12 weeks after starting the study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06793371

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

Recruiting
PHASE2Ages 40–85InterventionalTreatment
Cytokinetics
~60 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)Placebo to match CK-4021586

At a glance

Recruiting sites
24 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of early drug discontinuation
Measured over 12 weeks
+2 more outcomes measured

Conditions

Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

26 sites across 18 states
California5
Florida3
New York2
Texas2
Alabama1
Arizona1
Arkansas1
Illinois1

Study leadership

  • Cytokinetics MD · STUDY_DIRECTOR · Cytokinetics

Who to contact

Cytokinetics MD
[email protected]
650-624-2929
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Incidence of early drug discontinuation12 weeks

    Incidence of early drug discontinuation observed during dosing of CK 4021586 in patients with HFpEF

  • Incidence of LVEF < 40%12 weeks

    Incidence of left-ventricular ejection fraction (LVEF) \< 40% observed during dosing of CK-4021586 in patients with HFpEF

  • Incidence of AEs12 weeks

    Incidence of adverse events observed during dosing of CK-4021586 in patients with HFpEF