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Purpose

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).

Condition

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
This is a single group study where patients will transition from mavacamten to aficamten following a standardized protocol
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CMI 		Switching from mavacamten on day 1 to aficamten starting at week 2.
  • Drug: Aficamten
    Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.

Recruiting Locations

Oregon Health & Science University
Portland, Oregon 97239
Contact:
Ahmad Masri, MD
503-494-7551
masria@ohsu.edu

More Details

Status
Recruiting
Sponsor
Oregon Health and Science University

Study Contact

Ahmad Masri
503-494-7551
masria@ohsu.edu

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.