Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy (CMI-SWITCH)

Oregon Health & Science University (OHSU)

Status and phase: Enrolling; Phase 4

Conditions: Hypertrophic Cardiomyopathy (HCM)

Treatments: Drug: Aficamten

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07600177

STUDY00029878

007119 (Other Identifier)

Details and patient eligibility

About

This is an investigator-initiated two-center study. The goal of this study is to investigate the feasibility, safety and efficacy outcomes of a seamless transition from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented history of oHCM with documented resting and/or Valsalva LVOT obstruction ≥ 50 mmHg who are currently receiving mavacamten commercially.
• Echo-derived LVEF ≥55% on mavacamten at the time of enrollment.
• Patient willing to consent for the study and undergo the study procedures.

Exclusion criteria

• Severe aortic stenosis or sub-aortic obstruction
• Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM (eg, Noonan syndrome, Fabry disease, amyloidosis).
• History of LVEF <30%.
• Paroxysmal atrial fibrillation (AF) with documented episode within 3 months.
• Atrial fibrillation (paroxysmal or permanent) not on systemic anticoagulation.
• Documented history of current obstructive coronary artery disease (> 70% stenosis in one or more epicardial coronary arteries) or documented history of myocardial infarction.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

CMI

Experimental group

Description:

Switching from mavacamten on day 1 to aficamten starting at week 2.

Treatment:

Drug: Aficamten