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Exercise Training for Transthyretin Cardiac Amyloidosis

This study is looking at whether a personalized exercise program can help people with transthyretin cardiac amyloidosis (a heart condition where abnormal proteins build up in the heart). This condition often causes heart failure and makes it hard to exercise. While current treatments like tafamidis can slow the disease, they don't improve how well people can exercise. This study will involve 40 participants, aged 60 to 90, who have been diagnosed with transthyretin cardiac amyloidosis and heart failure. The main goal is to see if the exercise program improves your peak oxygen consumption (VO2), which measures how much oxygen your body can use during exercise, after 12 weeks. The study aims to improve your ability to exercise and your quality of life.

Study design
This interventional study plans to enroll 40 participants aged 60 to 90. It will test a supervised, personalized exercise training program.
What's involved
You would participate in two 60-minute supervised exercise training sessions per week. Your peak oxygen consumption will be measured at 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your peak oxygen consumption will be measured at 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05797857

Exercise Training in Transthyretin Cardiac Amyloidosis

Recruiting
NAAges 60–90InterventionalTreatment
Brigham and Women's Hospital
~40 participants
Updated 2025-03-18 on ClinicalTrials.gov
What's tested:Exercise Training

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
peak oxygen consumption (VO2)
Measured over 12 weeks

Conditions

Amyloid Cardiomyopathy
Transthyretin Cardiac Amyloidosis

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NCT05797857

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Brigham and Women's Hospital

    Boston, Massachusettsstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Sarah Cuddy, MD
[email protected]
6177328410
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • peak oxygen consumption (VO2)12 weeks

    CPET performed at baseline and 12-weeks, following the exercise intervention will be used to measure aerobic capacity, peak VO2. The change in peak VO2 from baseline to 12 weeks is the primary outcome measure. An increase of \> 1.0 ml/kg/min is considered a clinically meaningful increase