Status:
COMPLETED
TRAMmoniTTR Study Genetic Screening of an At-risk Population for hATTR and Monitoring of TTR Positive Subjects
Lead Sponsor:
CENTOGENE GmbH Rostock
Collaborating Sponsors:
Alnylam Pharmaceuticals
Conditions:
Transthyretin Amyloidosis
Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed 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,...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Informed consent is obtained from the participant
- The participant is 18 years of age or older
- The participant has no diagnosis of alcoholism according to international guidelines
- The participant has not undergone chemotherapy for any carcinoma
- AND
- The participant is at risk for hATTR due to two or more the factors listed below:
- cardiomyopathy or polyneuropathy with no obvious etiology atypical Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) or Motor Neuron Disease (MND)
- autonomic dysfunction
- hypertrophic cardiomyopathy or heart failure with preserved ejection fraction Left Ventricular Hypertrophy (LVH)
- bilateral carpal tunnel syndrome
- spinal stenosis or spinal radiculopathy
- gait disorders
- ocular changes involving vitreous opacities
- unexplained weight loss \>5kg
- renal abnormalities
- family history of hATTR
- based on imaging or biopsy suspected for the wild type TTR (ATTR) and not genetically tested for hATTR
- OR • The participant is diagnosed with hATTR
- OR
- • The participant is a 1st or 2nd degree relative of the TTR positive subject
- Exclusion Criteria
- Informed consent is not obtained from the participant
- The participant is younger than 18 years of age
- The participant has a diagnosis of alcoholism according to International guidelines
- The participant has undergone chemotherapy for any carcinoma
- The participant is not at risk for hATTR
Exclusion
Key Trial Info
Start Date :
July 20 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 16 2025
Estimated Enrollment :
5028 Patients enrolled
Trial Details
Trial ID
NCT03237494
Start Date
July 20 2017
End Date
May 16 2025
Last Update
June 29 2025
Active Locations (84)
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1
Kepler Universitätsklinikum, Klinik für Interne 1 - Kardiologie und internistische Intensivmedizin; Cardiology
Linz, Austria, 4021
2
Kepler Universitätsklinikum, Neuromed Campus; Neurology
Linz, Austria, 4021
3
Universitätsklinikum Aachen, Neurology
Aachen, Germany, 52074
4
Klinikum Westmünsterland GmbH, I. Medizinische Klinik und Interventionelle Kardiologie
Ahaus, Germany, 48683