Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Moderate Intensity Exercise Program

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator