EXCITE-HCM: Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

• Sponsor: University of California, San Francisco (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05818605
• Collaborator: National Institutes of Health (NIH) (NIH), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 70
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48.4
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertrophic Cardiomyopathy	Behavioral: Moderate Intensity Exercise Program	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, controlled, blindedRandomized, controlled, blinded
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The EXerCise traIning To rEcovery in HCM Trial
• Actual Study Start Date: Feb 17, 2023
• Anticipated Primary Completion Date: Mar 1, 2027
• Anticipated Study Completion Date: Mar 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: Moderate Intensity Exercise Program; 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
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

Outcome Measures

Primary Outcome Measures

1. Change in V O2 max [Baseline and 24 weeks]

   Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET

2. Change in peak VO2 % [Baseline and 24 weeks]

   Change in peak VO2 % predicted (%) by CPET

Secondary Outcome Measures

1. Change in Myocardial Systolic Strain [Baseline and 24 Weeks]

   Change in Myocardial systolic strain (%) by echocardiography

2. Change in Myocardial Work [Baseline and 24 weeks]

   Change Myocardial work (mmHg%) by echocardiography

Other Outcome Measures

1. Change in Myocardial Perfussion [Baseline and 24 Weeks]

   Change in Regional myocardial perfusion (ml/min/gm) by PET

2. Change in Coronary Flow reserve [Baseline and 24 Weeks]

   Change in coronary flow reserve (ratio, no unit) by PET

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California - San Francisco	San Francisco	California	United States	94143

Sponsors and Collaborators

• University of California, San Francisco
• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Theodore P Abraham, M.D, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT05818605
• Other Study ID Numbers: R01HL157238; R01HL157238
• First Posted: Apr 19, 2023
• Last Update Posted: Apr 19, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy

Study Results

No Results Posted as of Apr 19, 2023