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Evaluating CK-4021586 for heart failure with preserved ejection fraction

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

PHASE2 · Cytokinetics · NCT06793371

This study is testing a new medication for adults with heart failure and preserved ejection fraction to see if it is safe and what the best dose is to help improve their heart function and symptoms.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment60 (estimated)
Ages40 Years to 85 Years
SexAll
SponsorCytokinetics (industry)
Locations24 sites (Fairhope, Alabama and 23 other locations)
Trial IDNCT06793371 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study aims to assess the safety and tolerability of CK-4021586 in adults diagnosed with symptomatic heart failure with preserved ejection fraction (HFpEF). Participants will receive varying doses of the medication or a placebo in a blinded manner to determine the most effective and safe dosage. The study will include individuals aged 40 to 85 years with specific heart failure criteria, ensuring a targeted approach to treatment. The trial is designed to gather data on the drug's effects on heart function and symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 85 with symptomatic HFpEF and specific echocardiographic and biomarker criteria.

Not a fit: Patients with significant comorbidities or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from HFpEF, potentially improving their quality of life.

How similar studies have performed: While this approach is being explored in this specific context, similar studies have shown promise in evaluating treatments for HFpEF.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Fairhope, Alabama and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Symptomatic Heart Failure With Preserved Ejection Fraction, Symptomatic heart failure with preserved ejection fraction, HFpEF, Heart failure, CK-4021586, CK-586, AMBER-HFpEF, AMBER

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.