Actively Recruiting
Exercise Training in Transthyretin Cardiac Amyloidosis
Led by Brigham and Women's Hospital · Updated on 2025-03-18
40
Participants Needed
1
Research Sites
311 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exercise Training in Transthyretin Cardiac Amyloidosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis and typing of ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity
- Diagnosis of heart failure with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) 50 pg/ml
- Peak VO2 less than 80% predicted, indicating impaired aerobic capacity (for aim 2 only)
- Taking tafamidis (for aim 2 only)
- Able to walk 4 meters (with or without assistive device) and independent with basic activities of daily living at enrollment
- Adequate clinical stability judged by investigator to allow participation
- Signed informed consent indicating understanding of study purpose and procedures and willingness to participate
You will not qualify if you...
- Acute myocardial infarction diagnosed clinically
- More than 70% obstructive coronary artery disease
- Severe aortic valve stenosis
- Active participation in formal, facility-based cardiac exercise
- Regular moderate to vigorous exercise over 30 minutes twice per week consistently in previous 6 weeks
- Presence of ventricular assist device
- Light chain amyloidosis or other non-ATTR amyloidosis
- Advanced chronic kidney disease with estimated glomerular filtration rate less than 20 mL/min/1.73m2
- Any organ transplantation
- Terminal illness other than heart failure with life expectancy less than 1 year
- Pacemaker or implantable cardioverter-defibrillator with heart rate limits below expected exercise levels and unable to be reprogrammed
- Neuropathy due to transthyretin mutation
- Impairment from stroke, injury, or other medical conditions preventing participation
- Abnormal cardiopulmonary exercise testing requiring further management
- Dementia preventing exercise participation and protocol adherence
- High risk for non-adherence as determined by screening
- Inability or unwillingness to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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