Summary

Eligibility
for people ages 40-85 (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

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

Official Title

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

Keywords

Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF), Symptomatic heart failure with preserved ejection fraction, HFpEF, Heart failure, CK-4021586, CK-586, AMBER-HFpEF, AMBER, Cardiac myosin inhibitor, CMI, CY 9021, CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)

Eligibility

You can join if…

Open to people ages 40-85

  • 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), or sodium-glucose contransporter-2 (SGLT2)-inhibitors must be on stable doses for more than 4 weeks 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Francisco - Heart and Vascular Center accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • Profound Research LLC accepting new patients
    Pasadena 5381396 California 5332921 91105 United States
  • Blue Coast Research Center, LLC accepting new patients
    Vista 5406602 California 5332921 92081 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT06793371
Phase
Phase 2 Heart Failure Research Study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated