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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL157238 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Intensity Exercise arm | Experimental | 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. |
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| Usual physical activity arm | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate Intensity Exercise Program | Behavioral | Subjects 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in V O2 max | Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET | Baseline and 24 weeks |
| Change in peak VO2 % | Change in peak VO2 % predicted (%) by CPET | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Myocardial Systolic Strain | Change in Myocardial systolic strain (%) by echocardiography | Baseline and 24 Weeks |
| Change in Myocardial Work | Change Myocardial work (mmHg%) by echocardiography |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Myocardial Perfussion | Change in Regional myocardial perfusion (ml/min/gm) by PET | Baseline and 24 Weeks |
| Change in Coronary Flow reserve | Change in coronary flow reserve (ratio, no unit) by PET |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cynthia Partida-Higuera, CCRP | Contact | 415-514-1125 | Cynthia.Partida-Higuera@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Theodore P Abraham, M.D | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California - San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
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Randomized, controlled, blinded
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| Baseline and 24 weeks |
| Baseline and 24 Weeks |
| D001024 |
| Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |