Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
study ends around

Description

Summary

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

Official Title

A Follow-Up, Open-Label, Research Evaluation of Sustained Treatment With Aficamten (CK-3773274) in Hypertrophic Cardiomyopathy (HCM)

Keywords

Symptomatic Hypertrophic Cardiomyopathy (HCM), Obstructive Hypertrophic Cardiomyopathy, oHCM, CK-3773274, CK-274, Non obstructive hypertrophic cardiomyopathy, nHCM, HCM, Hypertrophic cardiomyopathy, Aficamten, REDWOOD-OLE, CY 6022, FOREST-HCM, Forest, Aficamten (5 - 20 mg)

Eligibility

You can join if…

Open to people ages 18-85

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

You CAN'T join 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.

Locations

  • UC San Diego Health - Sulpizio Cardiovascular Center
    La Jolla California 92037 United States
  • UCLA Health System - UCLA Cardiovascular Center
    Los Angeles California 90095 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Cytokinetics
ID
NCT04848506
Phase
Phase 2/3 Cardiomyopathy Research Study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated