NCT05818605Recruiting
Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
The EXerCise traIning To rEcovery in HCM Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 5 Apr 2023
- Start date
- 17 Feb 2023
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- University of California, San Francisco
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT05818605
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 17 Feb 2023 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- History of ICD placement in the previous 3 months
- Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
Other illness
- History of exercise-induced syncope or ventricular arrhythmias
- History of septal reduction therapy - surgery or ablation
- History of hypotensive response with exercise testing (\>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure \>20 mm Hg)
Lab values
- Left ventricular ejection fraction less than 50% by echocardiography
Other
- Life expectancy less than 12 months
- Pregnant or planned pregnancy
- Inability to exercise owing to any medical or other limitations
- Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.