Exercise Training in Transthyretin Cardiac Amyloidosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorBrigham and Women's Hospital
About 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
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Exercise Training
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov