An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM

Launched by CORXEL PHARMACEUTICALS · Oct 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called aficamten to see how well it works and how safe it is for Chinese patients with a heart condition known as obstructive hypertrophic cardiomyopathy (oHCM). The trial is an extension of an earlier study and aims to gather long-term information about the medication's effects on patients' heart function and how their bodies process the drug over time. The researchers are currently looking for participants aged between 65 and 74 who have completed a previous trial and have a specific heart function measurement indicating their heart is working well enough.

To participate, individuals must have completed a prior study involving a different heart medication and have a heart function measurement (known as LVEF) of 55% or higher. However, some people may not be eligible if they have had certain heart-related treatments or conditions recently. Participants in this trial can expect to take aficamten regularly and will be monitored for its effects on their heart health and overall well-being. This study is important for understanding how aficamten can help manage oHCM in patients long-term.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Completion of a Cytokinetics trial investigating CK-3773274
• • 2. LVEF ≥55% at the Screening Visit
• Exclusion Criteria:
• • 1. Has participated in another investigational device or drug study or received an investigational device or drug \<1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
• • 2. Since completion of a previous study of aficamten has:Developed new-onset paroxysmal or permanent atrial fibrillation (AF) requiring rhythm restoring treatment (e.g., direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \<30 days prior to screening. Patient may rescreen for JX01003 after 30 days if heart rate (HR) \<100 bpm and/or rhythm is stable \>30 days.
• • 3. Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation).
• • 4. Had a confirmed LVEF \<40% with an associated dose interruption during participation in a prior study with aficamten.
• • 5. History of appropriate implantable cardioverter defibrillator (ICD) shock within 30 days prior to screening.
• • 6. Has received treatment with mavacamten.