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NCT03237494 Clinical Trial

TRAMmoniTTR Study Genetic Screening of an At-risk Population for hATTR and Monitoring of TTR Positive Subjects

Cardiomyopathies Clinical Trial

— TRAMmoniTTR  

Official title:
Genetic Screening of an At-risk Population for Hereditary TransthyRetin-related AMyloidosis and Longitudinal Monitoring of TTR Positive Subjects- A Multicenter Epidemiological Longitudinal Protocol

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03237494
Other study ID # TRAM2 analysis
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2017
Est. completion date April 30, 2025

Study information
Verified date September 2023
Source CENTOGENE GmbH Rostock
Contact Sabine Roesner
Phone +49 381 80113657
Email sabine.roesner@centogene.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

National, multicenter, epidemiological, longitudinal protocol to investigate the hATTR prevalence in an at-risk population for Hereditary Transthyretin Amyloidosis (hATTR) and subjects diagnosed with hATTR, to monitor the clinical status in TTR positive subjects and to establish hATTR biomarker/s

Description:

Hereditary TransThyRetin Amyloidosis (hATTR) is a slowly progressive condition, that is transmitted as an autosomal dominant trait and is characterized by abnormal extracellular deposits of fibrillar, misfolded proteins (amyloid fibrils) in the body. Amyloid fibrils can be deposited in different body compartments, such as the nerves, heart, gastrointestinal tract, kidneys and brain, causing severe structural changes. More than 30 proteins can trigger the formation of amyloid fibrils, 5 of which can infiltrate the heart and cause cardiac amyloidosis. One of these amyloidogenic protein is transthyretin, formerly known as prealbumin. Transthyretin (TTR) is found primarily in the serum (secreted by the liver) and cerebrospinal fluid (secreted by the choroid plexus) and functions as a carrier for the hormone thyroxine (T4) and retinol-binding protein (bound to retinol or vitamin A). The destabilization of the TTR protein and the formation of misfolded TTR. It is the goal of this study to investigate the prevalence of Hereditary Transthyretin-related Amyloidosis (hATTR) in a cohort of 5.000 subjects are at risk for Hereditary Transthyretin Amyloidosis (hATTR) and subjects diagnosed with hATTR, to monitor the clinical status in TTR positive subjects and to establish hATTR biomarker/s.

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Study Design

Related Conditions & MeSH terms

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Sponsors (2)
Lead Sponsor Collaborator
CENTOGENE GmbH Rostock Alnylam Pharmaceuticals

Countries where clinical trial is conducted

Austria,  Germany,  Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Analysis of prevalance of hATTR mutations among a cohort of participants at risk for hATTR. DBS-based genetic analyses of TTR gene will be perfomed via the combination of the Next-Generation Sequencing (the mutation will be confirmed by Sanger sequencing) and the Multiplex ligation-dependent probe amplification. 4 years
Primary To monitor clinical status in TTR positive subjects. 8 Follow up visits within 24 months 4 years
Secondary Establishment of biomarker/s in TTR positive cohort. hATTR-positive samples will be analyzed for the identification of potential biomarkers (based on MS/MS-Tandem spectroscopy) and compared with the merged control samples in order establish a HAE specific biomarker. 4 years
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