Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
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
- Hypertrophic Cardiomyopathy (HCM)
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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CMI |
Switching from mavacamten on day 1 to aficamten starting at week 2. |
|
Recruiting Locations
Oregon Health & Science University
Portland, Oregon 97239
Portland, Oregon 97239
More Details
- Status
- Recruiting
- Sponsor
- Oregon Health and Science University