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:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT05196594
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of transthyretin amyloidosis documented by pathogenic transthyretin mutation;
* evidence of cardiac involvement on echocardiogram or MRI; amyloid deposit confirmed by Congo red staining or presence of myocardial scintigraphy with grade 2 or 3 uptake (with distant monoclonal gammopathy of uncertain significance (MGUS);
* in the presence of MGUS it is necessary to confirm the TTR protein in the tissue by immunohistochemistry or mass spectrometry. Non-consanguineous living with patients;
* Sign an informed consent form.
Exclusion Criteria:
* Inflammatory bowel disease or persistent diarrhea for more than two weeks;
* Use of antibiotics and/or prebiotic or probiotic supplements in the two months prior to collection;
* Concurrent participation in other clinical studies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05196594
Study Brief:
Protocol Section:
NCT05196594