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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Awards & highlights

EXCITE-HCM Trial 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.Check my eligibility
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.See study design
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.

EXCITE-HCM Trial 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.

EXCITE-HCM Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in V O2 max
Change in peak VO2 %
Secondary outcome measures
Change in Myocardial Systolic Strain
Change in Myocardial Work
Other outcome measures
Change in Coronary Flow reserve
Change in Myocardial Perfussion

EXCITE-HCM 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?

National Institutes of Health (NIH)NIH
2,685 Previous Clinical Trials
6,930,726 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,496 Previous Clinical Trials
11,934,619 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,820 Previous Clinical Trials
47,299,367 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age range of participants in this trial limited to those under 20 years old?

"Patients who are of legal consent and below the age of 80 can take part in this study."

Answered by AI

Who meets the criteria to become a participant in this research endeavor?

"For this trial, we are looking for 70 participants who suffer from hypertrophic cardiomyopathy and fall within the ages of 18 to 80. These potential patients must also have access to exercise equipment at home or a fitness centre, as well as be able to adhere the 24 week training program."

Answered by AI

Are they presently taking on new participants for this experiment?

"Affirmative, clinicaltrials.gov indicates that this medical trial is actively enrolling people. This research project was initially shared on February 17th 2023 and its details were recently refreshed on April 5th 2023. Seventy volunteers are required to participate at a single site."

Answered by AI

What is the sample size for this medical research project?

"Affirmative. Per the details on clinicaltrials.gov, this medical study is actively enrolling participants and was most recently updated on April 5th, 2023. Seventy patients need to be recruited from one site for participation in this trial."

Answered by AI
~47 spots leftby Mar 2027