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

Description

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

Conditions

Symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF)

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Symptomatic Heart Failure with Preserved Ejection Fraction (HFpEF)
Intervention / Treatment

-

Contacts and Locations

Cincinnati

The Linder Center for Research & Education at the Christ Hospital, Cincinnati, Ohio, United States, 45219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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), 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.
  • * 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.

Ages Eligible for Study

40 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cytokinetics,

Cytokinetics MD, STUDY_DIRECTOR, Cytokinetics

Study Record Dates

2026-09