Exercise Intolerance in Non-obstructive Hypertrophic Cardiomyopathy

Hypertrophic Cardiomyopathy Clinical Trial

— EXCITE-HCM  

Official title:

The EXerCise traIning To rEcovery in HCM Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05818605
• Other study ID #: R01HL157238
• Secondary ID: R01HL157238
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2023
• Est. completion date: March 1, 2027

Study information

• Verified date: April 2023
• Source: University of California, San Francisco
• Contact: Cynthia Partida-Higuera, CCRP
• Phone: 415-514-1125
• Email: Cynthia.Partida-Higuera[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: March 1, 2027
• Est. primary completion date: March 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

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

Locations

Country	Name	City	State
United States	University of California - San Francisco	San Francisco	California

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Myocardial Perfussion	Change in Regional myocardial perfusion (ml/min/gm) by PET	Baseline and 24 Weeks
Other	Change in Coronary Flow reserve	Change in coronary flow reserve (ratio, no unit) by PET	Baseline and 24 Weeks
Primary	Change in V O2 max	Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET	Baseline and 24 weeks
Primary	Change in peak VO2 %	Change in peak VO2 % predicted (%) by CPET	Baseline and 24 weeks
Secondary	Change in Myocardial Systolic Strain	Change in Myocardial systolic strain (%) by echocardiography	Baseline and 24 Weeks
Secondary	Change in Myocardial Work	Change Myocardial work (mmHg%) by echocardiography	Baseline and 24 weeks