The EXerCise traIning To rEcovery in HCM Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

• Ability to complete study related testing including online surveys and smart phone use

• Ability to perform 24 weeks of exercise training

Locations
United States
California
University of California - San Francisco
RECRUITING
San Francisco
Contact Information
Primary
Cynthia Partida-Higuera, CCRP
Cynthia.Partida-Higuera@ucsf.edu
415-514-1125
Time Frame
Start Date: 2023-02-17
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 70
Treatments
Experimental: Moderate Intensity Exercise arm
All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks.
No_intervention: Usual physical activity arm
Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study
Sponsors
Leads: University of California, San Francisco
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov