Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

Enrolling by invitation · Phase 2/Phase 3

Conditions studied: Symptomatic Hypertrophic Cardiomyopathy (HCM)

In brief

The purpose of this study is to collect long-term safety and tolerability data for aficamten.

Key facts

Study ID

NCT04848506

Run by

Cytokinetics

People needed

900

Starts

2021-05-06

Expected to finish

2028-03-01

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completion of a Cytokinetics trial investigating aficamten
• LVEF ≥ 55% at the Screening Visit

You may not qualify if…

• 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.

Where it is running

• Alaska Heart and Vascular Institute — Anchorage, Alaska, United States
• Mayo Clinic Building - Phoenix — Phoenix, Arizona, United States
• UC San Diego Health - Sulpizio Cardiovascular Center — La Jolla, California, United States
• Cedar-Sinai Medical Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center (Smidt Heart Institute) — Los Angeles, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Yale New Haven Hospital — New Haven, Connecticut, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Holy Cross Hospital / Cardiology Associates — Fort Lauderdale, Florida, United States
• Emory Clinic — Atlanta, Georgia, United States
• Piedmont Fayette Hospital — Fayetteville, Georgia, United States
• Northwestern University — Evanston, Illinois, United States
• The University of Kansas Medical Center — Kansas City, Kansas, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• Michigan Medicine - University of Michigan — Ann Arbor, Michigan, United States
• University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center) — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Morristown Medical Center — Morristown, New Jersey, United States
• Northwell Health North Shore University Hospital — Manhasset, New York, United States
• NYU Langone Health — New York, New York, United States
• Weill Cornell Medicine — New York, New York, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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