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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

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
Select...
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 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

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

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,816 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,889 Previous Clinical Trials
47,834,137 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,441 Total Patients Enrolled

Media Library

Moderate Intensity Exercise Program Clinical Trial Eligibility Overview. Trial Name: NCT05818605 — N/A
Hypertrophic Cardiomyopathy Research Study Groups: Moderate Intensity Exercise arm, Usual physical activity arm
Hypertrophic Cardiomyopathy Clinical Trial 2023: Moderate Intensity Exercise Program Highlights & Side Effects. Trial Name: NCT05818605 — N/A
Moderate Intensity Exercise Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT05818605 — N/A
~42 spots leftby Mar 2027
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