Actively Recruiting
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
Led by Oregon Health and Science University · Updated on 2026-05-20
40
Participants Needed
2
Research Sites
10 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
S
Saint Lukes Hospital Mid America Heart Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effectiveness of switching from mavacamten to aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM). This study focuses on patients who have documented oHCM with significant left ventricular outflow tract (LVOT) obstruction and are already receiving mavacamten. The study is investigator-initiated and conducted at two centers. Participants will stop taking mavacamten on day 1 of the study and then start aficamten two weeks later. This seamless transition aims to assess how well patients tolerate the change and the impact on their heart condition. The study is designed as an interventional trial without masking, and the treatment phase lasts up to 16 weeks. During the study, participants will be closely monitored for safety outcomes and changes in heart function. Assessments include measurements of LVOT gradients at rest and during Valsalva maneuver, blood tests for heart stress markers like NT-proBNP and troponin I, and evaluation of symptoms using the New York Heart Association functional classification. The total participation time covers up to 16 weeks with regular evaluations to track the transition effects.
CONDITIONS
Brief Title
Mavacamten to Aficamten Transition in Patients With Obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented history of obstructive hypertrophic cardiomyopathy with resting and/or Valsalva LVOT obstruction 50 mmHg
- Currently receiving mavacamten commercially
- Echo-derived left ventricular ejection fraction (LVEF) 55% on mavacamten at enrollment
- Willing to consent and undergo study procedures
You will not qualify if you...
- Severe aortic stenosis or sub-aortic obstruction
- Known infiltrative or storage disorders causing cardiac hypertrophy that mimic HCM (e.g., Noonan syndrome, Fabry disease, amyloidosis)
- History of left ventricular ejection fraction (LVEF) <30%
- Paroxysmal atrial fibrillation with episode within 3 months
- Atrial fibrillation not on systemic anticoagulation
- History of current obstructive coronary artery disease (> 70% stenosis) or myocardial infarction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 16 weeks
Participants stop mavacamten at enrollment and start aficamten 2 weeks later to manage obstructive hypertrophic cardiomyopathy.
Multiple visits during treatment period
Trial Site Locations
Total: 2 locations
1
St. Luke's Hospital - Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Not Yet Recruiting
2
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
A
Ahmad Masri
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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