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Exercise Program for Hypertrophic Cardiomyopathy (EXCITE-HCM Trial)

N/A

Recruiting

Led By Theodore P Abraham, M.D

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

History of septal reduction therapy - surgery or ablation

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of moderate exercise vs. usual activity on improving symptoms and cardiac function in people with HCM. 70 participants will be monitored over 24 weeks.

Who is the study for?

This trial is for adults aged 18-80 with non-obstructive hypertrophic cardiomyopathy, which means their heart muscle is abnormally thick. They should be able to exercise and use a smartphone for study tests. People can't join if they've had certain heart treatments recently, are pregnant or planning pregnancy, have a history of fainting or dangerous rhythms during exercise, severe heart failure symptoms recently, or a life expectancy under one year.

What is being tested?

The EXCITE-HCM study compares the effects of a moderate intensity exercise program against usual physical activity on symptom improvement and heart function in people with hypertrophic cardiomyopathy over 24 weeks. Participants will be randomly assigned to one of the two groups and monitored through various medical tests.

What are the potential side effects?

Since this trial involves an exercise program rather than medication, side effects may include typical risks associated with physical activity such as muscle strains or injuries. The specific condition of participants might also influence potential cardiac-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-80 years old with a diagnosis of hypertrophic cardiomyopathy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had surgery or ablation for thick heart muscle.

Select...

I have had severe heart failure or chest pain in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in V O2 max

Change in peak VO2 %

Secondary study objectives

Change in Myocardial Systolic Strain

Change in Myocardial Work

Other study objectives

Change in Coronary Flow reserve

Change in Myocardial Perfussion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Moderate Intensity Exercise armExperimental Treatment1 Intervention

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.

Group II: Usual physical activity armActive Control1 Intervention

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

0 / 3Eligibility criteria met