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).
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.
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.
Single group
Aficamten
DrugPatients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.
Safety Endpoints
To describe the safety of this proposed protocol. These include: 1. Participant incidence of reported AEs 2. Participant incidence of reported SAEs 3. Participant incidence of LVEF \< 40%
Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment
Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg
Proportional change from baseline in NT-proBNP and high-sensitivity troponin I
Proportional improvement in NYHA functional classification by 1 functional class
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Oregon Health and Science University
Lead sponsor
Saint Lukes Hospital Mid America Heart Institute
Collaborator
Cytokinetics
Collaborator
