NCT06793371 AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
| NCT ID | NCT06793371 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cytokinetics |
| Condition | Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-02-06 |
| Primary Completion | 2026-09 |
Trial Parameters
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Brief Summary
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
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 po
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