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Recruiting NCT06793371

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

Phase II Interventional Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg), Placebo to match CK-4021586.
Who it may be relevant to
Registry conditions: Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF). Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
    CK-4021586 administered orally
  • Drug Placebo to match CK-4021586
    Placebo administered orally

Primary outcome measures

  • Incidence of early drug discontinuation [Time frame: 12 weeks]
  • Incidence of LVEF < 40% [Time frame: 12 weeks]
  • Incidence of AEs [Time frame: 12 weeks]
Secondary outcome measures (5)
  • Change in NT-proBNP [Time frame: Baseline to Week 6 and Week 12]
  • Plasma concentrations of CK-4021586 [Time frame: 12 weeks]
  • Concentration-response relationship of CK-4021586 on NT-proBNP change [Time frame: Baseline to Week 12]
  • Concentration-response relationship of CK-4021586 to LVEF change [Time frame: Baseline to Week 12]
  • Change in LVEF [Time frame: Baseline to Week 6 and Week 12]

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 pose a risk to patient safety or interfere with the study evaluation, procedures, or completion.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 25 centers
  • Eastern Shore Research Institute, LLC — Fairhope
  • University of Arizona Sarver Heart Center — Tucson
  • John L. McClellan Memorial Veterans Hospital — Little Rock
  • BioSolutions Clinical Research Center — Imperial
  • Profound Research LLC — Pasadena
  • University of California, San Francisco - Heart and Vascular Center — San Francisco
  • FOMAT - Comprehensive Cardiovascular Care — Santa Maria
  • Blue Coast Research Center, LLC — Vista
  • … and 17 more centers

Identifiers

NCT: NCT06793371 · CY 9021 · 2024-516349-38-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗