Mass General - Division of Clinical Research

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

Purpose

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

Condition

Symptomatic Hypertrophic Cardiomyopathy (HCM)

Eligibility

Eligible Ages: Between 18 Years and 85 Years
Eligible Sex: All
Accepts 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.

Study Design

Phase: Phase 2/Phase 3
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Aficamten up to 20 mg	Patients in this arm take daily dose of aficamten. Each patient will start at the lowest prespecified dose and titrate up to their maximum tolerated dose.	Drug: Aficamten (5 - 20 mg) Aficamten tablets administered orally. During titration phase, clinic visits will occur approximately every 2-6 weeks. In the maintenance phase clinic visits will occur every 24 weeks, with safety check-in occurring every 12 weeks between visits by phone or, if desirable, in the clinic.

More Details

Status: Enrolling by invitation
Sponsor: Cytokinetics

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.