Status:
ENROLLING_BY_INVITATION
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM
Lead Sponsor:
Cytokinetics
Conditions:
Symptomatic Hypertrophic Cardiomyopathy (HCM)
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to collect long-term safety and tolerability data for aficamten.
Eligibility Criteria
Inclusion
- Completion of a Cytokinetics trial investigating aficamten
- LVEF ≥ 55% at the Screening Visit
Exclusion
- Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
- 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.
- Since completion of a previous trial of aficamten has:
- Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days
- Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
- Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
- History of implantable ICD placement within 30 days prior to screening.
Key Trial Info
Start Date :
May 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2028
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04848506
Start Date
May 6 2021
End Date
March 1 2028
Last Update
January 6 2026
Active Locations (116)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Alaska Heart and Vascular Institute
Anchorage, Alaska, United States, 99508
3
Mayo Clinic Building - Phoenix
Phoenix, Arizona, United States, 85054
4
UC San Diego Health - Sulpizio Cardiovascular Center
La Jolla, California, United States, 92037