Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
NCT ID:
NCT05797857
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
90 Years
Study:
NCT05797857
Study Brief:
Protocol Section:
NCT05797857