Exercise intervention trials in patients with hypertrophic cardiomyopathy (HCM) have demonstrated an association with improvement in resting and exercise hemodynamics, ventricular remodeling, and anxiety/depression. However, no randomized controlled trials (RCTs) to date have assessed the effects of exercise intervention in patients with HCM on cardiac myosin inhibitors (CMIs). This trial aims to evaluate the efficacy of a 12-week individualized exercise training program in HCM patients receiving aficamten.
Age 18-80 years.
Clinical diagnosis of HCM.
Able to perform endurance and resistance exercise.
Currently on stable dose of aficamten
Residual left ventricular outflow tract obstruction (peak gradient ≥50mmHg at rest).
Sustained ventricular arrhythmias or ICD shock within 6 months.
Pregnancy.
Severe valvular stenosis.
Parallel
Exercise Intervention
BehavioralA 3-month training plan with a gym membership including weekly personal training sessions. Subjects will also be given a Garmin Forerunner 55 smartwatch and Garmin HRM 200 chest strap to track heart rates during exercise.
Physical Activity Handout
BehavioralAn American Heart Association Physical Activity Recommendations handout will be provided, and a Garmin Forerunner 55 smartwatch will be given to subjects to wear during waking hours over 3-month period.
Peak oxygen consumption (Peak VO2)
CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure.
Ventilatory Efficiency (VE/VCO2 Slope)
Ventilatory efficiency is defined as the slope of minute ventilation to carbon dioxide production (VE/VCO2) and will be evaluated via CPET performed at baseline and at 12-weeks. A lower slope indicates improved ventilatory efficiency.
Kansas City Cardiomyopathy Questionnaire - Overall Summary (KCCQ-OS)
Quality of life questionnaire scaled from 0 to 100, where higher scores indicate better health status. This will be recorded at baseline and 12-weeks. An increase of 5 points is considered a clinically meaningful increase.
Short Form - 36 (SF-36)
The SF-36 is a general health survey to assess overall physical and mental health domains. Scores on each scale range from 0 to 100, with higher scores representing better health-related quality of life and higher overall functional capacity.
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