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Enrolling by invitation Phase 2/3

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

NCT04848506 · tracked via the Priya Life Science Australia tracker
Phase
Phase 2/3
Started
2021-05-06
Last updated
2026-10-13

Condition(s) studied

Symptomatic Hypertrophic Cardiomyopathy (HCM)

Investigational drug(s) / intervention(s)

Aficamten (5 - 20 mg) →

Aficamten (5 - 20 mg): Aficamten tablets, 5-20 mg daily, administered orally. Participants may continue on Aficamten until end of treatment criteria defined in the protocol is met.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Completion of a Cytokinetics trial investigating aficamten * LVEF ≥ 55% at the Screening Visit Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Incidence of adverse events observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
    Patient incidence of reported Adverse Events (AEs)
  • Incidence of serious adverse events observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
    Patient incidence of reported Serious Adverse Events (SAEs)
  • Incidence of left ventricular ejection fraction (LVEF) < 50% observed during dosing of aficamten in patients with HCM — Baseline to End of study, up to 5 years
    Patient incidence of reported LVEF \<50%

Trial sites (141)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Alaska Heart and Vascular Institute Anchorage Alaska
Mayo Clinic Building - Phoenix Phoenix Arizona
UC San Diego Health - Sulpizio Cardiovascular Center La Jolla California
Cedar-Sinai Medical Center Los Angeles California
Cedars-Sinai Medical Center (Smidt Heart Institute) Los Angeles California
UCLA Health System - UCLA Cardiovascular Center Los Angeles California
UCSF Medical Center San Francisco California
Yale New Haven Hospital New Haven Connecticut
MedStar Washington Hospital Center Washington D.C. District of Columbia
Holy Cross Hospital / Cardiology Associates Fort Lauderdale Florida
Emory Clinic Atlanta Georgia
Piedmont Fayette Hospital Fayetteville Georgia
The Queen's Medical Center Honolulu Hawaii
Northwestern University Chicago Illinois
The University of Iowa Hospitals & Clinics Iowa City Iowa
The University of Kansas Medical Center Kansas City Kansas
Massachusetts General Hospital Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts
Lahey Hospital & Medical Center Burlington Massachusetts
Michigan Medicine - University of Michigan Ann Arbor Michigan
University of Michigan Health System (UMHS) - University Hospital (University of Michigan Medical Center) Ann Arbor Michigan
Henry Ford Hospital Detroit Michigan
University of Minnesota Minneapolis Minnesota
Mayo Clinic Rochester Minnesota
Saint Luke's Hospital of Kansas City Kansas City Missouri
Morristown Medical Center Morristown New Jersey
Northwell Health North Shore University Hospital Manhasset New York
NYU Langone Health New York New York
Weill Cornell Medicine New York New York
Mount Sinai Hospital New York New York
Columbia University Medical Center/New York Presbyterian Hospital New York New York
Westchester Medical Center Valhalla New York
Sanger Heart & Vascular Institute, Atrium Health Charlotte North Carolina
Duke Cardiology at Southpoint Durham North Carolina
The Linder Research Center at The Christ Hospital Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
Cleveland Clinic Cleveland Ohio
Ascension St. John Clinical Research Institute Tulsa Oklahoma
Providence St. Vincent Medical Center Portland Oregon

+ 101 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04848506 on ClinicalTrials.gov ↗ ← All trials in Australia