RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This Phase 2 study tests doses of CK-4021586 to learn about its safety and how well people tolerate it. It is for adults ages 40 to 85 with symptoms of HFpEF, a type of heart failure where the heart’s pumping strength is preserved.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 85 years old at screening.
  • Have heart failure in NYHA class II or III, meaning symptoms limit physical activity.
  • Have a heart ultrasound showing that the heart pumps out at least 60% of the blood in its main pumping chamber with each beat.
  • Have an NT-proBNP blood test, which measures heart strain, of at least 300 pg/mL with a normal heart rhythm, or at least 900 pg/mL with atrial fibrillation or flutter (types of irregular heartbeat).
  • Have a body mass index (BMI), a measure based on height and weight, below 40.
  • If taking a beta-blocker, ACE inhibitor, ARB, or ARNI heart medicine, have no dose changes for more than 30 days before screening.
  • If taking a GLP-1 medicine, have no dose changes for more than 24 weeks before screening and no planned dose changes during the study.

Who can't join

  • Have another serious health problem, cancer, or active infection that the study doctor or medical monitor believes could make the study unsafe or affect study tests, procedures, or completion.
  • Other study rules for who can and cannot join also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (26)

AL

AR

AZ

CA

FL

IL

LA

MA

MN

MO

NJ

NY

OH

OR

TX

VA

WA

  • Swedish Heart & Vascular Institute, Advanced Cardiac Support Program · Seattle, WA 98122More trials in Seattle

WI