Recruiting

Exercise Training

Sponsor:

Brigham and Women's Hospital

Code:

NCT05797857

Conditions

Amyloid Cardiomyopathy

Transthyretin Cardiac Amyloidosis

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Training

Study Details

Brief summary:

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

Amyloid Cardiomyopathy

Transthyretin Cardiac Amyloidosis

Study ID

NCT05797857

Start date

Jul 10, 2024

Status verified date

Mar, 2025

Completion date

Jun 30, 2030

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention arm

Interventions

Exercise Training

A supervised, personalized exercise training program, which will consist of two 60-minute exercise training sessions per week.

Primary outcome measure

  • peak oxygen consumption (VO2) [ Time Frame: 12 weeks ]

Central Contacts and Locations

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Sarah Cuddy, MD

6177328410scuddy1@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Mar 18, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-03-18.