Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT05818605

Conditions

Hypertrophic Cardiomyopathy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Moderate Intensity Exercise Program

Study Details

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.

Conditions

Hypertrophic Cardiomyopathy

Study ID

NCT05818605

Start date

Feb 17, 2023

Status verified date

Nov, 2025

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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

Interventions

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

Primary outcome measure

  • Change in V O2 max [ Time Frame: Baseline and 24 weeks ]
  • Change in peak VO2 % [ Time Frame: Baseline and 24 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of California - San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Theodore P Abraham, M.D

More Information

Sponsor

University of California, San Francisco

Last update posted

Nov 20, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-11-20.