TRAMmoniTTR Study Genetic Screening of an At-risk Population for hATTR and Monitoring of TTR Positive Subjects
TRAMmoniTTR
Genetic Screening of an At-risk Population for Hereditary TransthyRetin-related AMyloidosis and Longitudinal Monitoring of TTR Positive Subjects- A Multicenter Epidemiological Longitudinal Protocol
1 other identifier
observational
5,028
3 countries
84
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 hATTR, to monitor the clinical status in TTR positive subjects and to establish hATTR biomarker/s
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2017
Longer than P75 for all trials
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 20, 2017
CompletedFirst Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 16, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 16, 2025
CompletedJune 29, 2025
September 1, 2024
7.8 years
July 31, 2017
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
To monitor clinical status in TTR positive subjects.
8 Follow up visits within 24 months
4 years
Secondary Outcomes (1)
Establishment of biomarker/s in TTR positive cohort.
4 years
Study Arms (1)
Participants at risk for hATTR and participants diagnosed with hATTR
Participants 18 years of age or older
Eligibility Criteria
Participants at risk for Hereditary Transthyretin Amyloidosis (hATTR) and participants diagnosed with hATTR
You may qualify if:
- 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
- +4 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CENTOGENE GmbH Rostocklead
- Alnylam Pharmaceuticalscollaborator
Study Sites (84)
Kepler Universitätsklinikum, Klinik für Interne 1 - Kardiologie und internistische Intensivmedizin; Cardiology
Linz, 4021, Austria
Kepler Universitätsklinikum, Neuromed Campus; Neurology
Linz, 4021, Austria
Universitätsklinikum Aachen, Neurology
Aachen, 52074, Germany
Klinikum Westmünsterland GmbH, I. Medizinische Klinik und Interventionelle Kardiologie
Ahaus, 48683, Germany
Kreiskrankenhaus Altenburg, Neurology
Altenburg, 04600, Germany
Sächsisches Krankenhaus Arnsdorf, Akademisches Lehrkrankenhaus der TU Dresden, Neurology
Arnsdorf, 01477, Germany
Gemeinschaftspraxis Neurologie & Psychiatrie im Stadtpalais
Aschaffenburg, 63739, Germany
Kerckhoff-Klinik GmbH, Klinik für Kardiologie, Cardiology
Bad Nauheim, 61231, Germany
RHÖN-KLINIKUM Campus Bad Neustadt, Neurology
Bad Neustadt an der Saale, 97616, Germany
Charité - Universitätsmedizin Berlin Funktionsdiagnostik und Stationen, Cardiology
Berlin, 10117, Germany
Charité Universitätsmedizin Berlin, Klinik für Neurologie, Neurology
Berlin, 10117, Germany
Sana Klinikum Lichtenberg
Berlin, 101365, Germany
Charité Universitätsmedizin Berlin - Campus Virchow Klinikum (CVK), Cardiology
Berlin, 13353, Germany
Klinikum Bielefeld, Klinik für Kardiologie und internistische Intensivmedizin, Cardiology
Bielefeld, 33604, Germany
Evangelisches Klinikum Bethel gGmbH v. Bodelschwinghsche Stiftungen Bethel, Neurology
Bielefeld, 33617, Germany
Klinikum Bremen Mitte gGmbH, Neurologische Klinik, Neurology
Bremen, 28177, Germany
Gesundheit Nord gGmbH - Klinikverband Bremen
Bremen, 28211, Germany
Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Cardiology
Buchholz in der Nordheide, 21244, Germany
Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Neurology
Buchholz in der Nordheide, 21244, Germany
Allgemeines Krankenhaus Celle, Neurology
Celle, 29223, Germany
Carl-Thiem-Klinikum Cottbus gGmbH
Cottbus, 03048, Germany
St. Vincenz Krankenhaus Datteln, Medizinische Klinik II, Cardiology
Datteln, 45711, Germany
Klinikum Dortmund gGmbH,Stroke-Unit und Neurologische Intensivstation, Neurology
Dortmund, 44137, Germany
LVR Klinikum Düsseldorf, Neurology
Düsseldorf, 40629, Germany
Martin Gropius Krankenhaus, Klinik für Neurologie, Neurology
Eberswalde, 16225, Germany
Universitätsklinikum Erlangen, Cardiology
Erlangen, 91045, Germany
Alfried Krupp Krankenhaus Rüttenscheid, Neurology
Essen, 45131, Germany
Contilia Herz- und Gefäßzentrum, Elisabeth-Krankenhaus Essen, Cardiology
Essen, 45138, Germany
Kliniken an der Paar Friedberg Krankenhaus, Cardiology
Friedberg, 86316, Germany
Herz-Thorax-Zentrum Fulda, Klinikum Fulda gAG, Universitätsmedizin Marburg - Campus Fulda, Cardiology
Fulda, 36043, Germany
University of Giessen-Marburg, Neurology
Giessen, D-35385, Germany
Universitätsmedizin Göttingen - Herzzentrum; Cardiology
Göttingen, 37075, Germany
Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität, Neurology
Greifswald, 17489, Germany
kbo-Isar-Amper-Klinikum München-Ost, Klinik für Neurologie, Neurology
Haar, 85540, Germany
Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie, Neurology
Halle, 06120, Germany
Universitätsklinik und Poliklinik für Innere Medizin III, Cardiology
Halle, 06120, Germany
Asklepios Klinik St. Georg, Klinik für Neurologie
Hamburg, 20099, Germany
Universitäres Herzzentrum Hamburg, Klinik für Allgemeine und Interventionelle Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Cardiology
Hamburg, 20246, Germany
Neurologie Neuer Wall, Fachärzte für Neurologie & Psychiatrie, Neurology
Hamburg, 20354, Germany
Albertinen-Krankenhaus, Cardiology
Hamburg, 22457, Germany
Asklepios Klinik Altona, Neurologische Abteilung mit überregionaler Stroke Unit, Neurophysiologie und Neurologischer Intensivmedizin
Hamburg, 22763, Germany
Medizinische Hochschule Hannover, Klinik für Neurologie; Neurology
Hanover, 30625, Germany
Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie, Cardiology
Heidelberg, 69120, Germany
Lausitzer Seenland Klinikum GmbH, Klinik für Neurologie, Neurology
Hoyerswerda, 02977, Germany
Universitätsklinikum Jena, Neurology
Jena, 07740, Germany
Universitätsklinikum Jena Klinik für Innere Medizin I
Jena, 07747, Germany
DRK-Kliniken Nordhessen gGmbH , Klinik für Neurologie und Klinische Neurophysiologie, Neurology
Kassel, 34121, Germany
Alexianer Krefeld GmbH, Krankenhaus Maria Hilf, Neurology
Krefeld, 47805, Germany
Universitaetsklinikum Leipzig, Neurology
Leipzig, 04103, Germany
Klinikum St. Georg gGmbH
Leipzig, 04129, Germany
Asklepios Fachklinikum Lübben, Neurology
Lubin, 15907, Germany
Universitäres Herzzentrum Lübeck, Medizinische Klinik II
Lübeck, 23538, Germany
Sana Kliniken Lübeck GmbH, Medizinische Klinik II
Lübeck, 23560, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, 23562, Germany
DRK Schmerz-Zentrum, Neurology
Mainz, 55131, Germany
Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Neurologie; Neurology
Mainz, Germany
Diakonissen Speyer-Mannheim, Diakonissenkrankenhaus Mannheim, Neurology
Mannheim, 68163, Germany
Neckar-Odenwald Kliniken gGmbH, Kreiskrankenhaus Mosbach, Kardiologie der Klinik für Innere Medizin
Mosbach, 74821, Germany
Ökumenisches Hainich Klinikum gGmbH, Neurology
Mühlhausen, 99974, Germany
Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik, Neurology
München, 80336, Germany
Kardiologie München Nord, Cardiology
München, 80939, Germany
Ludwig-Maximilians-Universität München, Klinikum Großhadern, Neurologische Klinik und Poliklinik & Deutsches Schwindel- und Gleichgewichtszentrum DSGZ, Neurology
München, 81377, Germany
Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar, Technische Universität München
München, 81675, Germany
Praxis für Neurologie, Neurology
München, 81825, Germany
Ruppiner Kliniken GmbH,Hochschulklinikum der MHB, Neurology
Neuruppin, 16816, Germany
UKRB Universitätsklinikum Ruppin Brandenburg
Neuruppin, 16816, Germany
Kreiskrankenhaus Prignitz gGmbH, Neurology
Perleberg, 19348, Germany
Krankenhaus Barmherzige Brüder Regensburg, Klinik für Neurologie, Neurology
Regensburg, 93049, Germany
Universitätsklinikum Regensburg, Cardiology
Regensburg, 93053, Germany
Nordwest-Krankenhaus Sanderbusch gGmbH, Neurologische Klinik, Neurology
Sande, 26452, Germany
Sächsisches Krankenhaus Altscherbitz, Neurology
Schkeuditz, 04435, Germany
Jung-Stilling Klinikum Siegen, Diakonie Westfalen Süd Neuro, Neurogeriatrie, Neurology
Siegen, 57074, Germany
Elbe Klinikum Stade
Stade, 21682, Germany
Asklepios Fachklinikum Teupitz, Neurology
Teupitz, 15755, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076, Germany
NeuroPoint, Neurology
Ulm, 89073, Germany
University of Ulm, Neurology
Ulm, 89081, Germany
Sophien-u.Hufeland-Klinikum, Klinik für Neurologie und Klinische Neurophysiologie, Neurology
Weimar, 99425, Germany
Fachkrankenhaus Hubertusburg gGmbH, Neurologische Klinik, Neurology
Wermsdorf, 04779, Germany
Sana HANSE Klinikum Wismar, Klinik für Neurologie, Neurology
Wismar, 23966, Germany
Praxis für Neurologie, Neurology
Wolfratshausen, v, Germany
Luzerner Kantonspital, Cardiology
Lucerne, 6000, Switzerland
Solothurner Spitäler AG, Bürgerspital Solothurn, Cardiology
Olten, 4500, Switzerland
Praxisgemeinschaft für Kardiologie, Innere Medizin und Psychosomatische Medizin, Cardiology
Zug, 6300, Switzerland
Biospecimen
Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Peter Bauer, Prof.
Centogene GmbH
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 2, 2017
Study Start
July 20, 2017
Primary Completion
May 16, 2025
Study Completion
May 16, 2025
Last Updated
June 29, 2025
Record last verified: 2024-09