Exercise Program for Hypertrophic Cardiomyopathy

(EXCITE-HCM Trial)

Overseen By Cynthia Partida-Higuera, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Exercise-induced syncope, Ventricular arrhythmias, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

70 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Moderate Intensity Exercise Program for Hypertrophic Cardiomyopathy?

Research shows that moderate intensity exercise is safe and can improve fitness in patients with hypertrophic cardiomyopathy, as it enhances peak oxygen uptake and cardiac function without causing serious side effects. ^{1 2 3 4 5}

Is moderate-intensity exercise safe for people with hypertrophic cardiomyopathy?

Research shows that moderate-intensity exercise is generally safe for people with hypertrophic cardiomyopathy, as no serious adverse events were reported in studies. However, high-intensity exercise is not recommended due to potential risks. ^{1 3 5 6 7}

How does the moderate intensity exercise program treatment for hypertrophic cardiomyopathy differ from other treatments?

The moderate intensity exercise program is unique because it focuses on improving fitness and cardiovascular health through physical activity, which is generally considered safe for patients with hypertrophic cardiomyopathy. Unlike drug treatments, this approach uses exercise to enhance cardiorespiratory fitness and potentially reduce cardiovascular mortality without the risks associated with high-intensity exercise. ^{1 2 3 5 6}

Research Team

Theodore P Abraham, M.D

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

Inclusion Criteria

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

Ability to complete study related testing including online surveys and smart phone use

Ability to perform 24 weeks of exercise training

Exclusion Criteria

I am being evaluated for heart surgery due to a blockage, less than 3 months ago.

I have had surgery or ablation for thick heart muscle.

You are not able to participate in physical activity because of health reasons or other limitations.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either moderate intensity exercise training or usual physical activity for 24 weeks

24 weeks

1 in-hospital visit, weekly video supervision

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Moderate Intensity Exercise Program

Trial Overview 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.

Participant Groups

Group I: Moderate Intensity Exercise arm Experimental Treatment 1 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 arm Active Control 1 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

Moderate Intensity Exercise Program is already approved in United States, European Union for the following indications:

Approved in United States as Moderate Intensity Exercise Program for:

• Hypertrophic Cardiomyopathy (HCM) without Left Ventricular Outflow Tract (LVOT) obstruction

Approved in European Union as Moderate Intensity Exercise Program for:

• Hypertrophic Cardiomyopathy (HCM)

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

In a study of 7666 adults with hypertrophic cardiomyopathy (HCM) followed for an average of 5.3 years, higher levels of physical activity (PA) were linked to lower rates of all-cause and cardiovascular mortality, indicating that being more active can be beneficial for this population.

Participants in the highest intensity PA group did not experience an increased risk of mortality compared to those in the middle PA group, suggesting that engaging in moderate-to-vigorous exercise is safe and may improve health outcomes for individuals with HCM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of physical activity with all-cause and cardiovascular mortality in 7666 adults with hypertrophic cardiomyopathy (HCM): more physical activity is better. Kwon, S., Lee, HJ., Han, KD., et al.[2021]

Patients with hypertrophic cardiomyopathy showed significantly reduced peak oxygen uptake (VO2 peak) and anaerobic threshold during exercise compared to healthy controls, indicating impaired exercise capacity.

The study identified potential mechanisms for exercise intolerance in these patients, including reduced stroke volume response, ventilation/perfusion mismatch, and abnormal peripheral oxygen utilization, based on the analysis of 50 patients aged 12 to 76 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiopulmonary responses to exercise in patients with hypertrophic cardiomyopathy. Jones, S., Elliott, PM., Sharma, S., et al.[2019]

Both high intensity training (HIT) and moderate intensity training (MIT) improved fitness levels in patients with hypertrophic cardiomyopathy, with HIT showing a slightly greater increase in peak oxygen uptake, but no significant statistical difference between the two methods.

The study found that exercise training led to beneficial changes in heart function, such as increased left ventricular end-diastolic volume, and importantly, no serious arrhythmias or adverse cardiac events were reported, indicating that both training methods are safe for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. MacNamara, JP., Dias, KA., Hearon, CM., et al.[2023]

Exercise echocardiography has become a key tool in assessing hypertrophic cardiomyopathy (HCM), helping to identify patients with provocable obstruction and predict future heart failure symptoms, which can influence treatment decisions like surgical myectomy or heart transplant.

Metabolic exercise testing provides a quantitative measure of functional limitations in HCM patients, aiding in risk stratification and determining eligibility for heart transplant, while also being safe and non-invasive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Exercise Testing in Hypertrophic Cardiomyopathy. Rowin, EJ., Maron, BJ., Olivotto, I., et al.[2019]

Individuals with hypertrophic cardiomyopathy (HCM) engage in significantly less moderate-vigorous physical activity (MVPA) compared to healthy controls, averaging only 86 minutes per day versus 140 minutes for controls, which may impact their overall health and exercise tolerance.

There is a positive correlation between peak oxygen consumption and MVPA in individuals with HCM, suggesting that increasing physical activity could improve their exercise capacity and potentially reduce the burden of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity, Inactivity and Sleep in Individuals with Hypertrophic Cardiomyopathy. Charman, SJ., Blain, AP., Okwose, NC., et al.[2023]

The RESET-HCM trial suggests that while moderate-intensity exercise is generally safe for patients with hypertrophic cardiomyopathy (HCM), the improvements in cardiorespiratory fitness from this type of training are only modest.

High-intensity exercise may provide significant benefits in increasing fitness levels, which could lead to lower cardiovascular mortality, potentially outweighing the risks associated with exercise in HCM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise Training for Patients With Hypertrophic Cardiomyopathy: JACC Review Topic of the Week. Dias, KA., Link, MS., Levine, BD.[2019]

Patients with hypertrophic cardiomyopathy (HC) reported lower levels of physical activity compared to the general population, which may increase their risk of obesity and cardiovascular issues.

Despite lower alcohol and tobacco use, the inactivity among HC patients negatively impacted their emotional well-being, highlighting the need for more research to find a safe balance between exercise risks and benefits for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity and other health behaviors in adults with hypertrophic cardiomyopathy. Reineck, E., Rolston, B., Bragg-Gresham, JL., et al.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

Association of physical activity with all-cause and cardiovascular mortality in 7666 adults with hypertrophic cardiomyopathy (HCM): more physical activity is better. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary responses to exercise in patients with hypertrophic cardiomyopathy. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trial of Moderate- and High-Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy: Effects on Fitness and Cardiovascular Response to Exercise. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Role of Exercise Testing in Hypertrophic Cardiomyopathy. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Physical Activity, Inactivity and Sleep in Individuals with Hypertrophic Cardiomyopathy. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Exercise Training for Patients With Hypertrophic Cardiomyopathy: JACC Review Topic of the Week. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Physical activity and other health behaviors in adults with hypertrophic cardiomyopathy. [2013]