NCT05818605 Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
| NCT ID | NCT05818605 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Hypertrophic Cardiomyopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2023-02-17 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2023-02-17 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. 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. 2. Left ventricular outflow tract gradient \<30 mmHg at rest and with provocation. 3. Left ventricular ejection fraction ≥ 50% by biplane Simpson's method. 4. Access to exercise equipment at home or at a fitness center. 5. Ability to complete study related testing including online surveys and smart phone use 6. Ability to perform 24 weeks of exercise training Exclusion Criteria: 1. History of exercise-induced syncope or ventricular arrhythmias 2. LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after 3. History of septal reduction therapy - surgery or ablation 4. History of ICD placement in the previous 3 months 5. 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) 6. 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 7. Left ventricular ejection fraction less than 50% by echocardiography 8. Life expectancy less than 12 months 9. Pregnant or planned pregnancy 10. Inability to exercise owing to any medical or other limitations 11. 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.
Contact & Investigator
Theodore P Abraham, M.D
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05818605 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Hypertrophic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05818605 currently recruiting?
Yes, NCT05818605 is actively recruiting participants. Contact the research team at Cynthia.Partida-Higuera@ucsf.edu for enrollment information.
Where is the NCT05818605 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05818605 clinical trial?
NCT05818605 is sponsored by University of California, San Francisco. The principal investigator is Theodore P Abraham, M.D at University of California, San Francisco. The trial plans to enroll 70 participants.