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Transthyretin AmyloidosisTRAMmoniTTRNCT03237494

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

An observational study of Transthyretin Amyloidosis and Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy, run by CENTOGENE GmbH Rostock at 84 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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 Read more about this study

Who is it for?
Ages 18 years and older
How many people
5,028 participants
Where
84 sitesin 3 countries
Study dates
20 Jul 2017to 16 May 2025
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants at risk for Hereditary Transthyretin Amyloidosis (hATTR) and participants diagnosed with hATTR

Who may be able to join

  • 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:
Show all 20Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

84 sites in 3 countries.

84 sites in 3 countries

Germany79 sites

  • Universitätsklinikum Aachen, Neurology

    Aachen, 52074

  • Klinikum Westmünsterland GmbH, I. Medizinische Klinik und Interventionelle Kardiologie

    Ahaus, 48683

  • Kreiskrankenhaus Altenburg, Neurology

    Altenburg, 04600

  • Sächsisches Krankenhaus Arnsdorf, Akademisches Lehrkrankenhaus der TU Dresden, Neurology

    Arnsdorf, 01477

  • Gemeinschaftspraxis Neurologie & Psychiatrie im Stadtpalais

    Aschaffenburg, 63739

  • Kerckhoff-Klinik GmbH, Klinik für Kardiologie, Cardiology

    Bad Nauheim, 61231

  • RHÖN-KLINIKUM Campus Bad Neustadt, Neurology

    Bad Neustadt an der Saale, 97616

  • Charité - Universitätsmedizin Berlin Funktionsdiagnostik und Stationen, Cardiology

    Berlin, 10117

  • Charité Universitätsmedizin Berlin, Klinik für Neurologie, Neurology

    Berlin, 10117

  • Sana Klinikum Lichtenberg

    Berlin, 101365

  • Charité Universitätsmedizin Berlin - Campus Virchow Klinikum (CVK), Cardiology

    Berlin, 13353

  • Klinikum Bielefeld, Klinik für Kardiologie und internistische Intensivmedizin, Cardiology

    Bielefeld, 33604

  • Evangelisches Klinikum Bethel gGmbH v. Bodelschwinghsche Stiftungen Bethel, Neurology

    Bielefeld, 33617

  • Klinikum Bremen Mitte gGmbH, Neurologische Klinik, Neurology

    Bremen, 28177

  • Gesundheit Nord gGmbH - Klinikverband Bremen

    Bremen, 28211

  • Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Cardiology

    Buchholz in der Nordheide, 21244

  • Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Neurology

    Buchholz in der Nordheide, 21244

  • Allgemeines Krankenhaus Celle, Neurology

    Celle, 29223

  • Carl-Thiem-Klinikum Cottbus gGmbH

    Cottbus, 03048

  • St. Vincenz Krankenhaus Datteln, Medizinische Klinik II, Cardiology

    Datteln, 45711

  • Klinikum Dortmund gGmbH,Stroke-Unit und Neurologische Intensivstation, Neurology

    Dortmund, 44137

  • LVR Klinikum Düsseldorf, Neurology

    Düsseldorf, 40629

  • Martin Gropius Krankenhaus, Klinik für Neurologie, Neurology

    Eberswalde, 16225

  • Universitätsklinikum Erlangen, Cardiology

    Erlangen, 91045

  • Alfried Krupp Krankenhaus Rüttenscheid, Neurology

    Essen, 45131

  • Contilia Herz- und Gefäßzentrum, Elisabeth-Krankenhaus Essen, Cardiology

    Essen, 45138

  • Kliniken an der Paar Friedberg Krankenhaus, Cardiology

    Friedberg, 86316

  • Herz-Thorax-Zentrum Fulda, Klinikum Fulda gAG, Universitätsmedizin Marburg - Campus Fulda, Cardiology

    Fulda, 36043

  • University of Giessen-Marburg, Neurology

    Giessen, D-35385

  • Universitätsmedizin Göttingen - Herzzentrum; Cardiology

    Göttingen, 37075

  • Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität, Neurology

    Greifswald, 17489

  • kbo-Isar-Amper-Klinikum München-Ost, Klinik für Neurologie, Neurology

    Haar, 85540

  • Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie, Neurology

    Halle, 06120

  • Universitätsklinik und Poliklinik für Innere Medizin III, Cardiology

    Halle, 06120

  • Asklepios Klinik St. Georg, Klinik für Neurologie

    Hamburg, 20099

  • Universitäres Herzzentrum Hamburg, Klinik für Allgemeine und Interventionelle Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Cardiology

    Hamburg, 20246

  • Neurologie Neuer Wall, Fachärzte für Neurologie & Psychiatrie, Neurology

    Hamburg, 20354

  • Albertinen-Krankenhaus, Cardiology

    Hamburg, 22457

  • Asklepios Klinik Altona, Neurologische Abteilung mit überregionaler Stroke Unit, Neurophysiologie und Neurologischer Intensivmedizin

    Hamburg, 22763

  • Medizinische Hochschule Hannover, Klinik für Neurologie; Neurology

    Hanover, 30625

  • Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie, Cardiology

    Heidelberg, 69120

  • Lausitzer Seenland Klinikum GmbH, Klinik für Neurologie, Neurology

    Hoyerswerda, 02977

  • Universitätsklinikum Jena, Neurology

    Jena, 07740

  • Universitätsklinikum Jena Klinik für Innere Medizin I

    Jena, 07747

  • DRK-Kliniken Nordhessen gGmbH , Klinik für Neurologie und Klinische Neurophysiologie, Neurology

    Kassel, 34121

  • Alexianer Krefeld GmbH, Krankenhaus Maria Hilf, Neurology

    Krefeld, 47805

  • Universitaetsklinikum Leipzig, Neurology

    Leipzig, 04103

  • Klinikum St. Georg gGmbH

    Leipzig, 04129

  • Universitäres Herzzentrum Lübeck, Medizinische Klinik II

    Lübeck, 23538

  • Sana Kliniken Lübeck GmbH, Medizinische Klinik II

    Lübeck, 23560

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23562

  • Asklepios Fachklinikum Lübben, Neurology

    Lubin, 15907

  • DRK Schmerz-Zentrum, Neurology

    Mainz, 55131

  • Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Neurologie; Neurology

    Mainz

  • Diakonissen Speyer-Mannheim, Diakonissenkrankenhaus Mannheim, Neurology

    Mannheim, 68163

  • Neckar-Odenwald Kliniken gGmbH, Kreiskrankenhaus Mosbach, Kardiologie der Klinik für Innere Medizin

    Mosbach, 74821

  • Ökumenisches Hainich Klinikum gGmbH, Neurology

    Mühlhausen, 99974

  • Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik, Neurology

    München, 80336

  • Kardiologie München Nord, Cardiology

    München, 80939

  • Ludwig-Maximilians-Universität München, Klinikum Großhadern, Neurologische Klinik und Poliklinik & Deutsches Schwindel- und Gleichgewichtszentrum DSGZ, Neurology

    München, 81377

  • Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar, Technische Universität München

    München, 81675

  • Praxis für Neurologie, Neurology

    München, 81825

  • Ruppiner Kliniken GmbH,Hochschulklinikum der MHB, Neurology

    Neuruppin, 16816

  • UKRB Universitätsklinikum Ruppin Brandenburg

    Neuruppin, 16816

  • Kreiskrankenhaus Prignitz gGmbH, Neurology

    Perleberg, 19348

  • Krankenhaus Barmherzige Brüder Regensburg, Klinik für Neurologie, Neurology

    Regensburg, 93049

  • Universitätsklinikum Regensburg, Cardiology

    Regensburg, 93053

  • Nordwest-Krankenhaus Sanderbusch gGmbH, Neurologische Klinik, Neurology

    Sande, 26452

  • Sächsisches Krankenhaus Altscherbitz, Neurology

    Schkeuditz, 04435

  • Jung-Stilling Klinikum Siegen, Diakonie Westfalen Süd Neuro, Neurogeriatrie, Neurology

    Siegen, 57074

  • Elbe Klinikum Stade

    Stade, 21682

  • Asklepios Fachklinikum Teupitz, Neurology

    Teupitz, 15755

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

  • NeuroPoint, Neurology

    Ulm, 89073

  • University of Ulm, Neurology

    Ulm, 89081

  • Sophien-u.Hufeland-Klinikum, Klinik für Neurologie und Klinische Neurophysiologie, Neurology

    Weimar, 99425

  • Fachkrankenhaus Hubertusburg gGmbH, Neurologische Klinik, Neurology

    Wermsdorf, 04779

  • Sana HANSE Klinikum Wismar, Klinik für Neurologie, Neurology

    Wismar, 23966

  • Praxis für Neurologie, Neurology

    Wolfratshausen, v

Other trials in Germany

Switzerland3 sites

  • Luzerner Kantonspital, Cardiology

    Lucerne, 6000

  • Solothurner Spitäler AG, Bürgerspital Solothurn, Cardiology

    Olten, 4500

  • Praxisgemeinschaft für Kardiologie, Innere Medizin und Psychosomatische Medizin, Cardiology

    Zug, 6300

Other trials in Switzerland

Austria2 sites

  • Kepler Universitätsklinikum, Klinik für Interne 1 - Kardiologie und internistische Intensivmedizin; Cardiology

    Linz, 4021

  • Kepler Universitätsklinikum, Neuromed Campus; Neurology

    Linz, 4021

Other trials in Austria

About this study

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

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

Read the 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, 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.

Keywords
Peripheral Nervous System Diseases, Transthyretin Amyloidosis, Transthyretin-related familial amyloid polyneuropathy, Transthyretin-related familial amyloid cardiomyopathy
Medical subject headings
Amyloidosis, Hereditary, Transthyretin-Related, Amyloid Neuropathies, Familial, Polyneuropathies, Cardiomyopathies, Peripheral Nervous System Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03237494
Study groupRoleWhat they receive
Participants at risk for hATTR and participants diagnosed with hATTRParticipants 18 years of age or older

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 4 years

  2. To monitor clinical status in TTR positive subjects.

    8 Follow up visits within 24 months

    Measured: 4 years

Secondary outcomes (1)

  1. 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.

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2017
  2. Study start20 Jul 2017
  3. Primary completion16 May 2025
  4. Study completion16 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,028 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03237494
Sponsor's protocol ID
TRAM2 analysis
Acronym
TRAMmoniTTR
Status last verified
Sep 2024
First submitted
31 Jul 2017
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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