RecruitingSymptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

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

Eligible age

40–85 yrs

Accepts

All genders

Locations

18 states

Healthy volunteers

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This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.

Sponsor: Cytokinetics

✓ 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.

✕ 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.