Actively Recruiting

Phase Not Applicable
Age: 60Years - 90Years
All Genders
NCT05797857

Exercise Training in Transthyretin Cardiac Amyloidosis

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

40

Participants Needed

1

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official 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 ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity
  • Diagnosis of heart failure with prior or current need of diuretics and increased N-terminal prohormone B-natureitic peptide (BNP) 50 pg/ml
  • Peak VO2 less than 80% predicted, indicating impaired aerobic capacity (for aim 2 only)
  • Taking tafamidis (for aim 2 only)
  • Able to walk 4 meters (with or without assistive device) and independent with basic activities of daily living at enrollment
  • Adequate clinical stability judged by investigator to allow participation
  • Signed informed consent indicating understanding of study purpose and procedures and willingness to participate
Not Eligible

You will not qualify if you...

  • Acute myocardial infarction diagnosed clinically
  • More than 70% obstructive coronary artery disease
  • Severe aortic valve stenosis
  • Active participation in formal, facility-based cardiac exercise
  • Regular moderate to vigorous exercise over 30 minutes twice per week consistently in previous 6 weeks
  • Presence of ventricular assist device
  • Light chain amyloidosis or other non-ATTR amyloidosis
  • Advanced chronic kidney disease with estimated glomerular filtration rate less than 20 mL/min/1.73m2
  • Any organ transplantation
  • Terminal illness other than heart failure with life expectancy less than 1 year
  • Pacemaker or implantable cardioverter-defibrillator with heart rate limits below expected exercise levels and unable to be reprogrammed
  • Neuropathy due to transthyretin mutation
  • Impairment from stroke, injury, or other medical conditions preventing participation
  • Abnormal cardiopulmonary exercise testing requiring further management
  • Dementia preventing exercise participation and protocol adherence
  • High risk for non-adherence as determined by screening
  • Inability or unwillingness to comply with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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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