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

Launched by CYTOKINETICS · Jan 21, 2025

Keywords

ClinConnect Summary

The AMBER-HFpEF trial is researching a new medication called CK-4021586 to determine its safety and how well it works for adults suffering from a condition known as heart failure with preserved ejection fraction (HFpEF). This condition means that the heart does not pump blood as effectively as it should, even though the heart's pumping ability looks normal on tests. The study is currently looking for participants aged between 40 and 85 who have been diagnosed with symptomatic HFpEF and meet certain health criteria, such as having a specific level of heart strain markers in their blood and a stable treatment plan with certain heart medications for at least a few weeks.

If you or a family member qualify and decide to participate, you will be part of a careful evaluation to understand how safe and tolerable this new treatment is. Participants will receive the study medication, but they won’t know whether they are getting the active drug or a placebo (a harmless pill with no active ingredients) to ensure the results are unbiased. Throughout the study, participants will have regular check-ups to monitor their health and any side effects. This trial is an important step in finding new treatments for heart failure, and your involvement could contribute valuable information to this area of research.

Gender

ALL

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), 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.
• 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.