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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the effects of moderate exercise on individuals with hypertrophic cardiomyopathy, a condition characterized by thickened heart walls. Participants will either follow a special exercise program or maintain their usual activities for 24 weeks. Researchers will evaluate whether exercise improves heart function and reduces symptoms. The trial seeks individuals diagnosed with hypertrophic cardiomyopathy who have access to exercise equipment at home or a gym and can commit to the study's activities. As an unphased trial, it offers a unique opportunity to contribute to understanding how exercise can benefit heart health in those with this condition.

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 prior data suggests that this exercise program is safe for individuals with hypertrophic cardiomyopathy?

Research shows that moderate exercise is generally safe for people with hypertrophic cardiomyopathy (HCM). Studies have found that this level of exercise does not worsen the condition and might even improve heart health. For instance, one study discovered that even high-intensity exercise did not worsen HCM symptoms and led to positive changes in the heart's structure.

While HCM can be associated with risks like sudden cardiac death, these risks are more often linked to high-intensity exercise. Moderate exercise, however, is usually well-tolerated. It boosts heart and lung fitness without causing major side effects.

In summary, moderate exercise appears safe for people with HCM, according to current research. However, individuals should consult their doctor before starting any new exercise routine. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for hypertrophic cardiomyopathy that often involve medications or surgical interventions, this new approach focuses on a moderate intensity exercise program. Researchers are excited about this trial because it explores how a structured exercise regimen, guided by certified professionals, might improve heart health and quality of life for patients in a way that's safe and sustainable. By integrating exercise as a core component, this method could offer a non-invasive alternative or complement to existing therapies, potentially reducing the need for medication and surgery.

What evidence suggests that this exercise program is effective for hypertrophic cardiomyopathy?

Research has shown that moderate exercise benefits people with hypertrophic cardiomyopathy (HCM). One study found that this exercise slightly increased exercise capacity, giving participants more stamina. Another study demonstrated that moderate exercise improved the coordination between the heart and lungs. Importantly, this exercise did not worsen the condition, indicating safety for HCM patients. In this trial, participants in the Moderate Intensity Exercise arm will follow a structured exercise program, which might help improve symptoms and heart function in people with HCM. ^{1 3 4 6 7}

Who Is on the Research Team?

Theodore P Abraham, M.D

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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.

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

I have had surgery or ablation for thick heart muscle.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 (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]

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]

Citations

1. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.031399

Randomized Controlled Trial of Moderate‐ and High‐ ... High intensity exercise was associated with salutary cardiac remodeling, and no progression of patients' hypertrophic cardiomyopathy, including ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5469299/

Effect of Moderate-Intensity Exercise Training on Peak ... In this preliminary study involving patients with hypertrophic cardiomyopathy, moderate-intensity exercise resulted in a small increase in exercise capacity at ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03335332

High Intensity Exercise for Increasing Fitness in Patients ... Moreover, moderate intensity exercise and HIE training significantly increases cardiorespiratory fitness in patients with cardiac disease. Such improvements ...

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Fit Hearts, Better Outcomes? A Systematic Review and ... ... Intervention to Increase Physical Activity in Patients with Hypertrophic Cardiomyopathy. ... Results of a Structured Exercise Training Program in a Cardiac ...

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High intensity exercise programme in patients with ... Physical activity in ... hypertrophic cardiomyopathy: results of a structured exercise training program in a cardiac rehabilitation center.

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Exercise and Hypertrophic Cardiomyopathy: Risks, Benefits ... Hypertrophic cardiomyopathy (HCM) is often associated with conservative exercise recommendations due to the risk of sudden cardiac death (SCD).

7. sciencedirect.com sciencedirect.com/science/article/pii/S1109966624001386

Shifting paradigms in hypertrophic cardiomyopathy Efficacy of exercise training in symptomatic patients with hypertrophic cardiomyopathy: results of a structured exercise training program in a cardiac ...