Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
All Genders
ID05797857

Personalized Exercise Training to Improve Functional Capacity in Transthyretin Cardiac Amyloidosis

Led by Brigham and Women's Hospital · Updated on 2025-03-18

40

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Transthyretin cardiac amyloidosis (ATTR-CM) causes serious heart failure primarily in older adults, affecting around 10% of those over 65 with heart failure. This condition leads to significant illness and death, with muscle problems starting years before heart failure symptoms. Researchers are studying a personalized exercise program to improve physical ability and quality of life for patients already receiving optimal treatment with tafamidis, the only approved medication that slows disease progression but does not improve exercise capacity. The study involves a supervised, personalized exercise training program with two 60-minute sessions per week for 12 weeks. The program aims to improve skeletal muscle function and aerobic capacity in people with ATTR-CM. Tests like cardiopulmonary exercise testing and muscle strength assessments will compare muscle performance between ATTR-CM patients and others with heart failure, and measure benefits from the exercise. Participants will be assessed with exercise tests, quality of life questionnaires, and physical function tests over the 12-week intervention. Researchers will monitor peak oxygen consumption and lower extremity function to evaluate improvements. The study requires participants to be clinically stable, able to walk and perform daily activities independently. The research will last until June 2030, with careful monitoring of safety and adherence throughout.

CONDITIONS

Brief Title

Exercise Training in Transthyretin Cardiac Amyloidosis

Who Can Participate

Age: 60Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis and typing of transthyretin cardiac amyloidosis by biopsy or specific imaging (Grade 2 or 3 pyrophosphate positivity)
  • Diagnosis of heart failure requiring diuretics and elevated N-terminal prohormone BNP (≥450 pg/ml)
  • Peak oxygen consumption (VO2) less than 80% predicted (for exercise intervention group)
  • Currently taking tafamidis medication (for exercise intervention group)
  • Able to walk 4 meters with or without assistive device and independent in basic daily activities
  • Clinically stable as judged by investigator to participate in the study
  • Signed informed consent showing understanding and willingness to participate
Not Eligible

You will not qualify if you...

  • Recent acute myocardial infarction based on clinical diagnosis
  • More than 70% obstructive coronary artery disease
  • Severe narrowing of the aortic valve (severe aortic stenosis)
  • Currently participating in formal, facility-based cardiac exercise
  • Regular moderate to vigorous exercise (>30 minutes, ≥2 times per week) consistently in past 6 weeks
  • Use of ventricular assist device
  • Presence of light chain amyloidosis or other non-transthyretin amyloidosis
  • Advanced kidney disease with estimated filtration rate below 20 mL/min/1.73m2
  • Any organ transplant recipient
  • Terminal illness other than heart failure with life expectancy less than 1 year
  • Pacemaker or defibrillator with heart rate limits incompatible with exercise and unable to reprogram
  • Neuropathy caused by transthyretin mutation
  • Impairment from stroke or other medical condition preventing participation
  • Abnormal exercise test findings needing further management
  • Dementia preventing exercise participation and protocol adherence
  • High risk of not following study procedures
  • Unable or unwilling to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants undergo a supervised, personalized exercise training program consisting of two 60-minute sessions per week to improve skeletal muscle performance and aerobic capacity.

Two 60-minute exercise sessions per week (in-person)

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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