The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.
Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
Access to exercise equipment at home or at a fitness center.
History of exercise-induced syncope or ventricular arrhythmias
LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
History of septal reduction therapy - surgery or ablation
History of ICD placement in the previous 3 months
Parallel
Moderate Intensity Exercise Program
BehavioralSubjects randomized to the EXER arm will undergo 24 weeks of Moderate Intensity Exercise Training (MIET). Patients will be signed up for 60-minute exercise sessions, 3 times a week
Change in V O2 max
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Change in peak VO2 %
Change in peak VO2 % predicted (%) by CPET
Change in Myocardial Systolic Strain
Change in Myocardial systolic strain (%) by echocardiography
Change in Myocardial Work
Change Myocardial work (mmHg%) by echocardiography
Change in Myocardial Perfussion
Change in Regional myocardial perfusion (ml/min/gm) by PET
Change in Coronary Flow reserve
Change in coronary flow reserve (ratio, no unit) by PET
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University of California, San Francisco
Lead sponsor
National Institutes of Health (NIH)
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
