Personalized exercise program for patients with transthyretin cardiac amyloidosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Brigham and Women's Hospital
  Boston, Massachusetts, United States Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Acoramidis for ATTR-CM: Cardiac Imaging Study

  This study tests whether acoramidis can improve heart structure and function in people with transthyretin amyloid cardiomyopathy.

  Recruiting Phase 4 Eidos Therapeutics, a BridgeBio company · St Louis, Missouri · NCT07695701

• Hungarian National Systemic Amyloidosis Registry

  This registry collects medical data from adults with systemic amyloidosis across Hungary to help understand how the disease is diagnosed and treated in real-world practice.

  Recruiting at 12 sites Semmelweis University · Balatonfüred and 11 other locations · NCT07689331

• 68Ga-FAPI-46 PET imaging to stage ATTR-CM and spot progression

  This study tests whether a gallium-68 labeled FAPI PET scan can help stage transthyretin cardiac amyloidosis and identify patients whose disease is progressing.

  Recruiting Phase 2 Nantes University Hospital · Nantes · NCT07549841

• Cardiac MRI blood-flow imaging to distinguish types of hypertrophic cardiomyopathy

  We will try cardiac MRI perfusion imaging to see if blood-flow patterns can distinguish people with different forms of hypertrophic cardiomyopathy, including genetic carriers and related conditions like Fabry disease and cardiac amyloidosis.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, BO · NCT07382128

• Enavogliflozin for Amyloid Cardiomyopathy

  This study tests whether Enavogliflozin helps people with amyloid cardiomyopathy and heart failure by comparing it to placebo in two treatment periods.

  Recruiting at 2 sites Phase 4 Seoul St. Mary's Hospital · Seoul and 1 other locations · NCT07240844

• AI-powered ECG tool to detect transthyretin cardiac amyloidosis early.

  This project will test whether the Willem™ AI ECG platform can tell people with transthyretin cardiac amyloidosis from those without using routine 12‑lead digital ECG recordings.

  Recruiting at 3 sites Idoven 1903 S.L. · Evanston, Illinois and 7 other locations · NCT06978660

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.