Status:
UNKNOWN
Analysis of the Instestinal Microbiome of Patients With Transthyretin Amyloidosis
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Amyloidosis, Hereditary, Transthyretin-Related
Microbial Colonization
Eligibility:
All Genders
18+ years
Brief Summary
Amyloidosis is a serious systemic disease. Cardiac involvement has a great impact on prognosis and can occur in its three main forms: acquired monoclonal light chain, hereditary transthyretinal and se...
Detailed Description
The scope of this study will be hereditary transthyretinal amyloidosis (hATTR). It is known that amyloidotic cardiomyopathy due to transthyretin deposition is an underdiagnosed cause of heart failure ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05196594
Start Date
May 1 2021
End Date
May 31 2023
Last Update
January 19 2022
Active Locations (1)
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1
University of Sao Paulo Medical School - The Heart Institute
São Paulo, Brazil, 05403-000