Clinical trial NCT05818605: Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy
Official title: The EXerCise traIning To rEcovery in HCM Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertrophic Cardiomyopathy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-04-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, blinded
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Change in V O2 max
timeFrame: Baseline and 24 weeks
measure: Change in peak VO2 %
timeFrame: Baseline and 24 weeks
Secondary outcomes:
measure: Change in Myocardial Systolic Strain
timeFrame: Baseline and 24 Weeks
measure: Change in Myocardial Work
timeFrame: Baseline and 24 weeks
Other outcomes:
measure: Change in Myocardial Perfussion
timeFrame: Baseline and 24 Weeks
measure: Change in Coronary Flow reserve
timeFrame: Baseline and 24 Weeks
Locations:
city: San Francisco
country: United States
facility: University of California - San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Theodore P Abraham, M.D
role: PRINCIPAL_INVESTIGATOR
References: