40 Participants Needed

Exercise Training for Amyloid Cardiomyopathy

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Brigham and Women's Hospital
Must be taking: Tafamidis
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, participants in aim 2 must be taking tafamidis, so you may need to continue that medication if you are already on it.

What data supports the effectiveness of this treatment for amyloid cardiomyopathy?

The research suggests that cardiopulmonary exercise testing (CPET) can help assess the functional capacity and predict outcomes in patients with cardiac amyloidosis, which may indirectly support the use of exercise training and rehabilitation in managing the condition.12345

Is exercise training safe for people with heart conditions?

Exercise training, including resistance and aerobic exercises, is generally safe for people with heart conditions like chronic heart failure and hypertension. Studies show it can improve muscle strength, exercise capacity, and quality of life without harmful effects on heart function.678910

How does exercise training differ from other treatments for amyloid cardiomyopathy?

Exercise training is unique because it focuses on improving heart function and overall health through physical activity, rather than using medications or surgery. It includes endurance, resistance, and respiratory exercises, which can enhance exercise capacity, quality of life, and reduce hospitalizations, making it a holistic approach compared to traditional treatments.1112131415

What is the purpose of this trial?

Transthyretin cardiac amyloidosis causes debilitating heart failure in older adults. The proposed research will develop a personalized exercise training program to improve functional capacity in patients on optimal treatment for transthyretin cardiac amyloidosis. This is a vital next step to improve functional capacity and quality of life of people suffering from transthyretin cardiac amyloidosis.

Eligibility Criteria

This trial is for older adults with transthyretin cardiac amyloidosis who can walk and are independent in daily activities. They must be on stable medical treatment, not already doing regular intense exercise, and have heart failure symptoms with a specific biomarker level. People with certain other health conditions or devices like pacemakers that limit exercise aren't eligible.

Inclusion Criteria

I can walk 4 meters on my own and take care of myself.
Your ability to take in oxygen during exercise is less than 80% of what is expected for someone like you.
I have heart failure, need diuretics, and my BNP levels are high.
See 4 more

Exclusion Criteria

I do not have any conditions like a stroke that would stop me from joining the study.
You have more than 70% blockage in your coronary arteries.
I do not have dementia affecting my ability to exercise or follow study instructions.
See 14 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 12 weeks of supervised personalized exercise training to improve functional capacity

12 weeks
Weekly supervised exercise sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Exercise Training
Trial Overview The study aims to create a personalized exercise program for patients with transthyretin cardiac amyloidosis to improve their ability to perform physical tasks and enhance life quality. Participants will follow this tailored exercise regimen while being monitored for its effects on their heart condition.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Intervention armExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Findings from Research

In a study of 56 patients with wild-type transthyretin amyloidosis (ATTRwt), increased levels of the VE/VCO2 ratio, along with C-reactive protein, sodium, and creatinine, were identified as significant risk factors for mortality, indicating their potential role in assessing patient outcomes.
The study found that patients with a VE/VCO2 ratio greater than 40 had a significantly lower median survival of 38.54 months compared to 88.69 months for those with a ratio of 40 or less, suggesting that VE/VCO2 could be a useful measure for evaluating the severity of ATTRwt cardiomyopathy.
Use of Ventilatory Efficiency Slope as a Marker for Increased Mortality in Wild-Type Transthyretin Cardiac Amyloidosis.Yunis, A., Doros, G., Luptak, I., et al.[2020]
In a study of 33 patients with wild-type transthyretin cardiac amyloidosis treated with tafamidis, low peak oxygen consumption (VO2) and peak circulatory power (CP) were found to be significant predictors of worse outcomes, including mortality and the need for heart transplant or palliative care.
Patients who had an exercise duration of less than 5.5 minutes during cardiopulmonary exercise testing also showed a higher risk of adverse outcomes, highlighting the importance of exercise capacity in assessing prognosis for these patients.
Prognostic Role of Cardiopulmonary Exercise Testing in Wild-Type Transthyretin Amyloid Cardiomyopathy Patients Treated With Tafamidis.Dalia, T., Acharya, P., Chan, WC., et al.[2022]
In a study of 72 patients with Transthyretin amyloid cardiomyopathy, the CardioPulmonary Exercise Test (CPET) revealed that a significant number of patients (36%) had inadequate blood pressure responses during exercise, indicating potential cardiovascular issues.
The study found that right ventricular function, specifically measured by tricuspidal s' wave, was a strong independent predictor of exercise capacity and ventilatory efficiency, highlighting its importance in assessing patients with ATTR cardiomyopathy.
Poor right ventricular function is associated with impaired exercise capacity and ventilatory efficiency in transthyretin cardiac amyloid patients.Bartolini, S., Baldasseroni, S., Fattirolli, F., et al.[2021]

References

Use of Ventilatory Efficiency Slope as a Marker for Increased Mortality in Wild-Type Transthyretin Cardiac Amyloidosis. [2020]
Prognostic Role of Cardiopulmonary Exercise Testing in Wild-Type Transthyretin Amyloid Cardiomyopathy Patients Treated With Tafamidis. [2022]
Poor right ventricular function is associated with impaired exercise capacity and ventilatory efficiency in transthyretin cardiac amyloid patients. [2021]
Prognostic value of cardiopulmonary exercise testing in cardiac amyloidosis. [2022]
Peak V'O2 is an independent predictor of survival in patients with cardiac amyloidosis. [2019]
Comprehensive rehabilitation in chronic heart failure. [2013]
An evidence-based guide to the efficacy and safety of isometric resistance training in hypertension and clinical implications. [2023]
[Heart patient and sports]. [2008]
Resistance exercise training in patients with heart failure. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Role of resistance training in heart disease. [2019]
[Exercise Training and Physical Activity in Patients with Heart Failure]. [2018]
Effects of Concurrent, Within-Session, Aerobic and Resistance Exercise Training on Functional Capacity and Muscle Performance in Elderly Male Patients with Chronic Heart Failure. [2023]
[Cardiac rehabilitation in patients with heart failure--is there a treatment beyond pharmacotherapy, surgery and device implantation?]. [2013]
[Rehabilitative intervention after a myocardial infarct]. [2006]
15.United Statespubmed.ncbi.nlm.nih.gov
Effects of exercise training on left ventricular volumes and function in patients with nonischemic cardiomyopathy: application of magnetic resonance myocardial tagging. [2022]
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