Evaluating CK-4021586 for heart failure with preserved ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Eastern Shore Research Institute, LLC
  Fairhope, Alabama, United States Recruiting
• University of Arizona Sarver Heart Center
  Tucson, Arizona, United States Recruiting
• John L. McClellan Memorial Veterans Hospital
  Little Rock, Arkansas, United States Recruiting
• BioSolutions Clinical Research Center
  Imperial, California, United States Recruiting
• Profound Research LLC
  Pasadena, California, United States Recruiting
• University of California, San Francisco - Heart and Vascular Center
  San Francisco, California, United States Recruiting

Study contacts

• Study coordinator: Cytokinetics MD
• Email: medicalaffairs@cytokinetics.com
• Phone: 650-624-2929

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Resmetirom for MASH with HFpEF in adults

  This study tests whether resmetirom can be given safely and show liver-related effects in adults with MASH and heart failure with preserved ejection fraction over 24 weeks.

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• Iron infusion and MRI to study inflammation in HFpEF

  A small early-phase study tests whether an iron infusion affects heart inflammation in people with HFpEF, using MRI measures before and after treatment.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.