Exercise Training in Transthyretin Cardiac Amyloidosis

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how a personalized exercise training program can help improve the physical abilities and overall quality of life for older adults suffering from transthyretin cardiac amyloidosis, a condition that can lead to serious heart failure. The research aims to see if tailored exercise can benefit patients who are already receiving standard treatments.

To participate in the trial, individuals should be diagnosed with transthyretin cardiac amyloidosis and have experienced heart failure. They should also be able to walk a short distance, like 4 meters, even if they need some help. Participants will be asked to sign a consent form, confirming they understand the study and want to take part. Those who are currently undergoing intensive exercise programs or have certain severe heart or health conditions may not be eligible. If you join the study, you can expect to engage in a customized exercise plan designed to enhance your fitness and daily life activities.

Gender

ALL

Eligibility 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