Personalized exercise program for patients with transthyretin cardiac amyloidosis
Personalized Exercise Training to Improve Functional Capacity in Transthyretin Cardiac Amyloidosis
This study is testing a personalized exercise program to see if it can help people with transthyretin cardiac amyloidosis feel stronger and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 60 Years to 90 Years |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05797857 on ClinicalTrials.gov |
What this trial studies
This research aims to develop a personalized exercise training program to enhance functional capacity in patients diagnosed with transthyretin cardiac amyloidosis (ATTR-CM) who are already receiving optimal treatment. The study will utilize cardiopulmonary exercise testing and a short physical performance battery to assess skeletal muscle performance and aerobic capacity. By focusing on improving skeletal muscle function, the study seeks to enhance the quality of life for individuals suffering from this debilitating condition. Participants will engage in a 12-week supervised exercise intervention tailored to their specific needs.
Who should consider this trial
Good fit: Ideal candidates include older adults diagnosed with ATTR-CM who are currently on tafamidis and have impaired aerobic capacity.
Not a fit: Patients with acute myocardial infarction or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the quality of life and functional capacity for patients with transthyretin cardiac amyloidosis.
How similar studies have performed: While exercise interventions have been explored in various heart failure populations, this specific approach for ATTR-CM is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis and typing of ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity (exception: nonamyloid control arm in aim 1). * Diagnosis of heart failure, with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) (≥450 pg/ml). * Peak VO2 \<80% predicted, indicating impaired aerobic capacity (for aim 2 only). * Taking tafamidis (for aim 2 only) * Able to walk 4 meters (with or without the use of an assistive device) and independent with basic activities of daily living at the time of enrolment. * Adequate clinical stability has been achieved in the judgment of the investigator to allow participation in study assessments and the intervention. * Signed informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study. Exclusion Criteria: * Acute myocardial infarction (Note: given that cardiac biomarkers such as troponin are frequently elevated in ATTR-CM patients, the diagnosis of acute myocardial infarction should be based on clinical diagnosis, not biomarkers alone) * \>70% obstructive coronary artery disease * Severe aortic valve stenosis * Already actively participating in formal, facility-based cardiac exercise * Already engaging in regular moderate to vigorous exercise conditioning defined as \> 30 minutes per day, ≥ twice per week consistently during the previous 6 weeks * Ventricular assist device * Light chain amyloidosis or other form of non-ATTR amyloidosis * Advanced chronic kidney disease defined as estimated glomerular filtration rate \<20 mL/min/1.73m2 * Any organ transplantation * Terminal illness other than HF with life expectancy \< 1 year * Pacemaker or implantable cardioverter-defibrillato (ICD) with heart rate limits \< expected heart rates for exercise and unable to be reprogrammed * Neuropathy due to transthyretin (TTR) mutation * Impairment from stroke, injury or other medical disorder that precludes participation in the intervention * Abnormal cardiopulmonary exercise testing (CPET) finding that requires further investigation and management * Dementia that precludes ability to participate in exercise and follow study protocols * High risk for non-adherence as determined by screening evaluation * Inability or unwillingness to comply with the study requirements
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.