RECRUITING

Exercise Training in Transthyretin Cardiac Amyloidosis

Conditions

Amyloid Cardiomyopathy Transthyretin Cardiac Amyloidosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Personalized Exercise Training to Improve Functional Capacity in Transthyretin Cardiac Amyloidosis

Quick Facts

Study Start:2024-05-01

Study Completion:2030-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05797857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:60 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-01

Study Completion Date2030-06-30

Study Record Updates

Study Start Date2024-05-01

Study Completion Date2030-06-30

Terms related to this study

Additional Relevant MeSH Terms

Amyloid Cardiomyopathy
Transthyretin Cardiac Amyloidosis