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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients will be switched from mavacamten to aficamten. Mavacamten will be stopped at enrollment, and aficamten started 2 weeks later.
St. Luke's Hospital - Mid America Heart Institute
Kansas City, Missouri, United States
NOT_YET_RECRUITINGOregon Health & Science University
Portland, Oregon, United States
RECRUITINGSafety 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%
Time frame: Up to 16 weeks
Proportional change from baseline in resting and Valsalva LVOT gradients during each assessment
Time frame: Up to 16 weeks
Proportion of participants with resting LVOT gradient < 30 mmHg and Valsalva LVOT gradient < 50 mmHg
Time frame: Up to 16 weeks
Proportional change from baseline in NT-proBNP and high-sensitivity troponin I
Time frame: Up to 16 weeks
Proportional improvement in NYHA functional classification by 1 functional class
Time frame: Up to 16 weeks
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