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New treatment option for Amyloid Cardiomyopathy
Official title Exercise Training in Transthyretin Cardiac Amyloidosis
ClinicalTrials.gov ID: NCT05797857
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 90
You may be able to join if
- Diagnosis and typing of ATTR-CM by endomyocardial biopsy or by Grade 2 or Grade 3 pyrophosphate (PYP) positivity (exception: nonamyloid control arm...
- 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.
You likely can't join if
- Acute myocardial infarction (Note: given that cardiac biomarkers such as troponin are frequently elevated in ATTR-CM patients, the diagnosis of acute...
- \>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...
- Ventricular assist device
See the full eligibility 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...
- \>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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.