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

October 10, 2023 updated by: CENTOGENE GmbH Rostock

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

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Sabine Roesner
Phone Number: +49 381 80113657
Email: sabine.roesner@centogene.com

Study Locations

Austria
- - Linz, Austria, 4021
    - Completed
    - Kepler Universitätsklinikum, Klinik für Interne 1 - Kardiologie und internistische Intensivmedizin; Cardiology
  - Linz, Austria, 4021
    - Completed
    - Kepler Universitätsklinikum, Neuromed Campus; Neurology
Germany
- - Aachen, Germany, 52074
    - Recruiting
    - Universitätsklinikum Aachen, Neurology
    - Contact:
      
      Andrea Maier, MD
      
      Phone Number: +49 (0)2418088600
      
      Email: amaier@ukaachen.de
    - Sub-Investigator:
      
      Maike Franziska Dohrn, MD
    - Principal Investigator:
      
      Andrea Maier, MD
  - Ahaus, Germany, 48683
    - Recruiting
    - Klinikum Westmünsterland GmbH, I. Medizinische Klinik und Interventionelle Kardiologie
    - Principal Investigator:
      
      Alessandro Cuneo, MD
    - Contact:
      
      Alessandro Cuneo, MD
      
      Phone Number: +49 (0)25619923471
      
      Email: a.cuneo@kmh-stadtlohn.de
  - Altenburg, Germany, 04600
    - Recruiting
    - Kreiskrankenhaus Altenburg, Neurology
    - Contact:
      
      Jörg Berrouschot, MD
      
      Phone Number: +49 (0)3447521380
      
      Email: neurologie@klinikum-altenburgerland.de
    - Principal Investigator:
      
      Jörg Berrouschot, MD
  - Arnsdorf, Germany, 01477
    - Completed
    - Sächsisches Krankenhaus Arnsdorf, Akademisches Lehrkrankenhaus der TU Dresden, Neurology
  - Aschaffenburg, Germany, 63739
    - Recruiting
    - Gemeinschaftspraxis Neurologie & Psychiatrie im Stadtpalais
    - Contact:
      
      Jochen C. Ulzheimer, MD
      
      Phone Number: +49 (0)6021449860
      
      Email: j-c-u@gmx.de
    - Principal Investigator:
      
      Jochen C. Ulzheimer, MD
  - Bad Nauheim, Germany, 61231
    - Recruiting
    - Kerckhoff-Klinik GmbH, Klinik für Kardiologie, Cardiology
    - Contact:
      
      Andreas Rieth, MD
      
      Phone Number: +49 (0)60329962000
      
      Email: a.rieth@kerckhoff-klinik.de
    - Principal Investigator:
      
      Andreas Rieth, MD
  - Bad Neustadt An Der Saale, Germany, 97616
    - Recruiting
    - RHÖN-KLINIKUM Campus Bad Neustadt, Neurology
    - Contact:
      
      Hassan Soda, MD
      
      Phone Number: +49 (0)97716622356
      
      Email: hassan.soda@campus-nes.de
    - Principal Investigator:
      
      Hassan Soda, MD
  - Berlin, Germany, 10117
    - Recruiting
    - Charité - Universitätsmedizin Berlin Funktionsdiagnostik und Stationen, Cardiology
    - Contact:
      
      Florian Knebel, MD
      
      Phone Number: +49 (0)30450513216
      
      Email: Fabian.Knebel@charite.de
    - Principal Investigator:
      
      Florian Knebel, MD
  - Berlin, Germany, 10117
    - Recruiting
    - Charité Universitätsmedizin Berlin, Klinik für Neurologie, Neurology
    - Contact:
      
      Katrin Hahn, MD
      
      Phone Number: +49 (0)30450660049
      
      Email: Katrin.Hahn@charite.de
    - Principal Investigator:
      
      Katrin Hahn, MD
  - Berlin, Germany, 13353
    - Recruiting
    - Charité Universitätsmedizin Berlin - Campus Virchow Klinikum (CVK), Cardiology
    - Principal Investigator:
      
      Carsten Tschöpe, MD
    - Contact:
      
      Carsten Tschöpe, MD
      
      Phone Number: +49 (0)30450565499
      
      Email: Carsten.Tschoepe@charite.de
  - Bielefeld, Germany, 33604
    - Recruiting
    - Klinikum Bielefeld, Klinik für Kardiologie und internistische Intensivmedizin, Cardiology
    - Contact:
      
      Christoph Stellbrink, MD
      
      Phone Number: +49 (0)5215813481
      
      Email: christoph.stellbrink@klinikumbielefeld.de
    - Principal Investigator:
      
      Christoph Stellbrink, MD
  - Bielefeld, Germany, 33617
    - Recruiting
    - Evangelisches Klinikum Bethel gGmbH v. Bodelschwinghsche Stiftungen Bethel, Neurology
    - Contact:
      
      Wolf-Rüdiger Schäbitz, MD
      
      Phone Number: +49 (0)52177278301
      
      Email: Wolf.Schaebitz@evkb.de
    - Principal Investigator:
      
      Wolf-Rüdiger Schäbitz, MD
  - Bremen, Germany, 28177
    - Completed
    - Klinikum Bremen Mitte gGmbH, Neurologische Klinik, Neurology
  - Bremen, Germany, 28211
    - Recruiting
    - Gesundheit Nord gGmbH - Klinikverband Bremen
    - Contact:
      
      Thomas Duning, MD
      
      Phone Number: +49 (0)4214081286
      
      Email: Thomas.duning@gesundheitnord.de
    - Principal Investigator:
      
      Thomas Duning, MD
  - Buchholz In Der Nordheide, Germany, 21244
    - Recruiting
    - Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Cardiology
    - Contact:
      
      Klaus Hertting, MD
      
      Phone Number: +49 (0)4181131340
      
      Email: klaus.hertting@krankenhaus-buchholz.de
    - Principal Investigator:
      
      Klaus Hertting, MD
  - Buchholz In Der Nordheide, Germany, 21244
    - Completed
    - Krankenhaus Buchholz und Winsen, gemeinnützige GmbH, Neurology
  - Celle, Germany, 29223
    - Recruiting
    - Allgemeines Krankenhaus Celle, Neurology
    - Contact:
      
      Philipp Ettelt, MD
      
      Phone Number: +49 (0)5141721400
      
      Email: Philipp.Ettelt@akh-celle.de
    - Principal Investigator:
      
      Ettelt Philipp, MD
  - Cottbus, Germany, 03048
    - Recruiting
    - Carl-Thiem-Klinikum Cottbus gGmbH
    - Contact:
      
      Alexander Dressel, MD
      
      Phone Number: +49 (0)355462476
      
      Email: A.Dressel@ctk.de
    - Principal Investigator:
      
      Alexander Dressel, MD
  - Datteln, Germany, 45711
    - Recruiting
    - St. Vincenz Krankenhaus Datteln, Medizinische Klinik II, Cardiology
    - Contact:
      
      Marcus Bauer, MD
      
      Phone Number: +49 (0)23631083140
      
      Email: m.bauer@vincenz-datteln.de
    - Principal Investigator:
      
      Marcus Bauer, MD
  - Dortmund, Germany, 44137
    - Recruiting
    - Klinikum Dortmund gGmbH,Stroke-Unit und Neurologische Intensivstation, Neurology
    - Contact:
      
      Gernot Reimann, MD
      
      Phone Number: +49 (0)23195321822
      
      Email: gernot.reimann@klinikumdo.de
    - Principal Investigator:
      
      Gernot Reimann, MD
  - Düsseldorf, Germany, 40629
    - Recruiting
    - LVR Klinikum Düsseldorf, Neurology
    - Contact:
      
      Rüdiger Seitz, MD
      
      Phone Number: +49 (0)2119224601
      
      Email: ruediger.seitz@lvr.de
    - Principal Investigator:
      
      Rüdiger Seitz, MD
  - Eberswalde, Germany, 16225
    - Completed
    - Martin Gropius Krankenhaus, Klinik für Neurologie, Neurology
  - Erlangen, Germany, 91045
    - Recruiting
    - Universitätsklinikum Erlangen, Cardiology
    - Contact:
      
      Steffan Achenbach, MD
      
      Phone Number: +49 (0)91318535301
      
      Email: stephan.achenbach@uk-erlangen.de
    - Principal Investigator:
      
      Steffan Achenbach, MD
  - Essen, Germany, 45138
    - Recruiting
    - Contilia Herz- und Gefäßzentrum, Elisabeth-Krankenhaus Essen, Cardiology
    - Contact:
      
      Robert Schueler, MD
      
      Phone Number: +49 (0)2018973200
      
      Email: R.Schueler@contilia.de
    - Principal Investigator:
      
      Robert Schueler, MD
  - Essen, Germany, 45131
    - Completed
    - Alfried Krupp Krankenhaus Rüttenscheid, Neurology
  - Friedberg, Germany, 86316
    - Completed
    - Kliniken an der Paar Friedberg Krankenhaus, Cardiology
  - Fulda, Germany, 36043
    - Recruiting
    - Herz-Thorax-Zentrum Fulda, Klinikum Fulda gAG, Universitätsmedizin Marburg - Campus Fulda, Cardiology
    - Contact:
      
      Volker Schächinger, MD
      
      Phone Number: +49 (0)661845381
      
      Email: volker.schaechinger@klinikum-fulda.de
    - Principal Investigator:
      
      Volker Schächinger, MD
  - Giessen, Germany, D-35385
    - Recruiting
    - University of Giessen-Marburg, Neurology
    - Contact:
      
      Manfred Kaps, MD
      
      Phone Number: +49 (0)64198545301
      
      Email: Manfred.Kaps@neuro.med.uni-giessen.de
    - Principal Investigator:
      
      Manfred Kaps, MD
  - Greifswald, Germany, 17489
    - Completed
    - Universitätsklinikum Greifswald der Ernst-Moritz-Arndt-Universität, Neurology
  - Göttingen, Germany, 37075
    - Recruiting
    - Universitätsmedizin Göttingen - Herzzentrum; Cardiology
    - Contact:
      
      Frauke Czepluch, MD
      
      Phone Number: +49 (0)551398900
      
      Email: f.czepluch@med.uni-goettingen.de
    - Principal Investigator:
      
      Frauke Czepluch, MD
  - Haar, Germany, 85540
    - Completed
    - kbo-Isar-Amper-Klinikum München-Ost, Klinik für Neurologie, Neurology
  - Halle (Saale), Germany, 06120
    - Recruiting
    - Martin-Luther-Universität, Universitätsklinik und Poliklinik für Neurologie, Neurology
    - Contact:
      
      Bernhard Sehm, MD
      
      Phone Number: +49 (0)3455572205
      
      Email: bernhard.sehm@uk-halle.de
    - Principal Investigator:
      
      Bernhard Sehm, MD
  - Halle (Saale), Germany, 06120
    - Recruiting
    - Universitätsklinik und Poliklinik für Innere Medizin III, Cardiology
    - Contact:
      
      Alexander Vogt, MD
      
      Phone Number: +49 (0)3453455572601
      
      Email: alexander.vogt@uk-halle.de
    - Principal Investigator:
      
      Alexander Vogt, MD
  - Hamburg, Germany, 20099
    - Completed
    - Asklepios Klinik St. Georg, Klinik für Neurologie
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitäres Herzzentrum Hamburg, Klinik für Allgemeine und Interventionelle Kardiologie, Universitätsklinikum Hamburg-Eppendorf, Cardiology
    - Contact:
      
      Monica Patten-Hamel, MD
      
      Phone Number: +49 (0)40741057975
      
      Email: patten@uke.de
    - Principal Investigator:
      
      Monica Patten-Hamel, MD
  - Hamburg, Germany, 22457
    - Recruiting
    - Albertinen-Krankenhaus, Cardiology
    - Contact:
      
      Eva Cramer-Frommann, MD
      
      Phone Number: +49 (0)4055886722
      
      Email: eva.cramer@albertinen.de
    - Principal Investigator:
      
      Herbert Naegele, MD
  - Hamburg, Germany, 20354
    - Completed
    - Neurologie Neuer Wall, Fachärzte für Neurologie & Psychiatrie, Neurology
  - Hamburg, Germany, 22763
    - Completed
    - Asklepios Klinik Altona, Neurologische Abteilung mit überregionaler Stroke Unit, Neurophysiologie und Neurologischer Intensivmedizin
  - Hannover, Germany, 30625
    - Recruiting
    - Medizinische Hochschule Hannover, Klinik für Neurologie; Neurology
    - Contact:
      
      Thomas Skripuletz, MD
      
      Phone Number: +49 (0)5115323816
      
      Email: skripuletz.thomas@mh-hannover.de
    - Principal Investigator:
      
      Thomas Skripuletz, MD
  - Heidelberg, Germany, 69120
    - Recruiting
    - Universitätsklinikum Heidelberg, Klinik für Kardiologie, Angiologie und Pneumologie, Cardiology
    - Contact:
      
      Fabian aus dem Siepen, MD
      
      Phone Number: +49 (0)62215637678
      
      Email: Fabian.ausdemSiepen@med.uni-heidelberg.de
    - Principal Investigator:
      
      Fabian aus dem Siepen, MD
  - Hoyerswerda, Germany, 02977
    - Completed
    - Lausitzer Seenland Klinikum GmbH, Klinik für Neurologie, Neurology
  - Jena, Germany, 07740
    - Recruiting
    - Universitätsklinikum Jena, Neurology
    - Contact:
      
      Otto W. Witte, MD
      
      Phone Number: +49 (0)36419323401
      
      Email: Otto.Witte@med.uni-jena.de
    - Principal Investigator:
      
      Otto W. Witte, MD
  - Kassel, Germany, 34121
    - Completed
    - DRK-Kliniken Nordhessen gGmbH , Klinik für Neurologie und Klinische Neurophysiologie, Neurology
  - Krefeld, Germany, 47805
    - Completed
    - Alexianer Krefeld GmbH, Krankenhaus Maria Hilf, Neurology
  - Leipzig, Germany, 04103
    - Recruiting
    - Universitaetsklinikum Leipzig, Neurology
    - Contact:
      
      Petra Baum, MD
      
      Phone Number: +49 (0)3419724248
      
      Email: petra.baum@medizin.uni-leipzig.de
    - Principal Investigator:
      
      Petra Baum, MD
  - Leipzig, Germany, 04129
    - Recruiting
    - Klinikum St. Georg gGmbH
    - Contact:
      
      Ilka Schneider, MD
      
      Phone Number: +49 (0)3419094268
      
      Email: ilka.schneider@sanktgeorg.de
    - Principal Investigator:
      
      Ilka Schneider, MD
  - Lübben, Germany, 15907
    - Completed
    - Asklepios Fachklinikum Lübben, Neurology
  - Lübeck, Germany, 23538
    - Recruiting
    - Universitäres Herzzentrum Lübeck, Medizinische Klinik II
    - Contact:
      
      Tobias Graf, MD
      
      Phone Number: +49 (0)45150044520
      
      Email: Tobias.Graf@uksh.de
    - Principal Investigator:
      
      Tobias Graf, MD
  - Lübeck, Germany, 23560
    - Recruiting
    - Sana Kliniken Lübeck GmbH, Medizinische Klinik II
    - Contact:
      
      Joachim Weil, MD
      
      Phone Number: +49 (0)4515851681
      
      Email: Joachim.Weil@Sana.de
    - Principal Investigator:
      
      Joachim Weil, MD
  - Mainz, Germany, 55131
    - Completed
    - DRK Schmerz-Zentrum, Neurology
  - Mainz, Germany
    - Recruiting
    - Johannes Gutenberg-Universität Mainz, Klinik und Poliklinik für Neurologie; Neurology
    - Contact:
      
      Frank Birklein, MD
      
      Phone Number: +49 (0)6131175486
      
      Email: frank.birklein@unimedizin-mainz.de
    - Principal Investigator:
      
      Frank Birklein, MD
  - Mannheim, Germany, 68163
    - Completed
    - Diakonissen Speyer-Mannheim, Diakonissenkrankenhaus Mannheim, Neurology
  - Mosbach, Germany, 74821
    - Recruiting
    - Neckar-Odenwald Kliniken gGmbH, Kreiskrankenhaus Mosbach, Kardiologie der Klinik für Innere Medizin
    - Contact:
      
      Peter Oberst, MD
      
      Phone Number: +49 (0)6261838430
      
      Email: Peter.Oberst@Neckar-Odenwald-Kliniken.de
    - Principal Investigator:
      
      Peter Oberst, MD
  - Mühlhausen, Germany, 99974
    - Completed
    - Ökumenisches Hainich Klinikum gGmbH, Neurology
  - München, Germany, 80336
    - Recruiting
    - Friedrich-Baur-Institut, Neurologische Klinik und Poliklinik, Neurology
    - Contact:
      
      Beate Schlotter-Weigel, MD
      
      Phone Number: +49 (0)89440057400
      
      Email: Beate.Schlotter-Weigel@med.uni-muenchen.de
    - Principal Investigator:
      
      Beate Schlotter-Weigel, MD
  - München, Germany, 80939
    - Recruiting
    - Kardiologie München Nord, Cardiology
    - Contact:
      
      Hans Ullrich Ebersberger, MD
      
      Phone Number: +49 (0)8985633450
      
      Email: info@kardiologie-mn.de
    - Principal Investigator:
      
      Hans Ullrich Ebersberger, MD
  - München, Germany, 81377
    - Recruiting
    - Ludwig-Maximilians-Universität München, Klinikum Großhadern, Neurologische Klinik und Poliklinik & Deutsches Schwindel- und Gleichgewichtszentrum DSGZ, Neurology
    - Contact:
      
      Florian Schöberl, MD
      
      Phone Number: +49 (0)89440076674
      
      Email: Florian.Schoeberl@med.uni-muenchen.de
    - Principal Investigator:
      
      Florian Schöberl, MD
  - München, Germany, 81675
    - Recruiting
    - Klinik und Poliklinik für Neurologie, Klinikum rechts der Isar, Technische Universität München
    - Contact:
      
      Achim Berthele, MD
      
      Phone Number: 4673 +49 (0)894140
      
      Email: achim.berthele@tum.de
    - Contact:
      
      Marcus Deschauer, MD
      
      Phone Number: 4606 +49 (0)894140
      
      Email: marcus.deschauer@mri.tum.de
    - Principal Investigator:
      
      Achim Berthele, MD
  - München, Germany, 81825
    - Completed
    - Praxis für Neurologie, Neurology
  - Neuruppin, Germany, 16816
    - Completed
    - Ruppiner Kliniken GmbH,Hochschulklinikum der MHB, Neurology
  - Perleberg, Germany, 19348
    - Recruiting
    - Kreiskrankenhaus Prignitz gGmbH, Neurology
    - Contact:
      
      Marko Petrick, MD
      
      Phone Number: +49 (0)3876303160
      
      Email: m.petrick@krankenhaus-prignitz.de
    - Principal Investigator:
      
      Marko Petrick, MD
  - Regensburg, Germany, 93049
    - Recruiting
    - Krankenhaus Barmherzige Brüder Regensburg, Klinik für Neurologie, Neurology
    - Contact:
      
      Lukas Kremmler, MD
      
      Phone Number: +49 (0)94136992427
      
      Email: Lukas.Kremmler@barmherzige-regensburg.de
    - Principal Investigator:
      
      Lukas Kremmler, MD
  - Regensburg, Germany, 93053
    - Recruiting
    - Universitätsklinikum Regensburg, Cardiology
    - Contact:
      
      Bernhard Unsöld, MD
      
      Phone Number: +49 (0)9419447201
      
      Email: bernhard.unsoeld@ukr.de
    - Principal Investigator:
      
      Bernhard Unsöld, MD
  - Sande, Germany, 26452
    - Completed
    - Nordwest-Krankenhaus Sanderbusch gGmbH, Neurologische Klinik, Neurology
  - Schkeuditz, Germany, 04435
    - Recruiting
    - Sächsisches Krankenhaus Altscherbitz, Neurology
    - Contact:
      
      Anne-Dorte Sperfeld, MD
      
      Phone Number: +49 (0)34204872300
      
      Email: Anne-Dorte.Sperfeld@skhal.sms.sachsen.de
    - Principal Investigator:
      
      Anne-Dorte Sperfeld, MD
  - Siegen, Germany, 57074
    - Recruiting
    - Jung-Stilling Klinikum Siegen, Diakonie Westfalen Süd Neuro, Neurogeriatrie, Neurology
    - Contact:
      
      Christian Tanislav, MD
      
      Phone Number: +49 (0)27133340392
      
      Email: christian.tanislav@diakonie-sw.de
    - Principal Investigator:
      
      Christian Tanislav, MD
  - Stade, Germany, 21682
    - Recruiting
    - Elbe Klinikum Stade
    - Contact:
      
      Holger Schmidt, MD
      
      Phone Number: +49 (0)4141 970
      
      Email: holger.schmidt@elbekliniken.de
    - Principal Investigator:
      
      Holger Schmidt, MD
  - Teupitz, Germany, 15755
    - Completed
    - Asklepios Fachklinikum Teupitz, Neurology
  - Tübingen, Germany, 72076
    - Recruiting
    - Universitätsklinikum Tübingen, Zentrum für Neurologie
    - Contact:
      
      Alexander Grimm, MD
      
      Phone Number: +49 (0)70712982342
      
      Email: alexander.grimm@med.uni-tuebingen.de
    - Principal Investigator:
      
      Alexander Grimm, MD
  - Ulm, Germany, 89073
    - Recruiting
    - NeuroPoint, Neurology
    - Contact:
      
      Herbert Schreiber, MD
      
      Phone Number: +49 (0)73160280440
      
      Email: schreiber@neurologie-ulm.de
    - Principal Investigator:
      
      Herbert Schreiber, MD
  - Ulm, Germany, 89081
    - Recruiting
    - University of Ulm, Neurology
    - Contact:
      
      Albert Ludolph, MD
      
      Phone Number: +49 (0)7311771201
      
      Email: albert.ludolph@rku.de
    - Principal Investigator:
      
      Albert Ludolph, MD
  - Weimar, Germany, 99425
    - Recruiting
    - Sophien-u.Hufeland-Klinikum, Klinik für Neurologie und Klinische Neurophysiologie, Neurology
    - Contact:
      
      Rolf Malessa, MD
      
      Phone Number: +49 (0)3643571300
      
      Email: neurologie@klinikum-weimar.de
    - Principal Investigator:
      
      Rolf Malessa, MD
  - Wermsdorf, Germany, 04779
    - Recruiting
    - Fachkrankenhaus Hubertusburg gGmbH, Neurologische Klinik, Neurology
    - Contact:
      
      Adrian Trommer, MD
      
      Phone Number: +49 (0)3436460
      
      Email: adrian.trommer@googlemail.com
    - Principal Investigator:
      
      Adrian Trommer, MD
  - Wismar, Germany, 23966
    - Recruiting
    - Sana HANSE Klinikum Wismar, Klinik für Neurologie, Neurology
    - Contact:
      
      Sabine Mehnert, MD
      
      Phone Number: +49 (0)3841331262
      
      Email: sabine.mehnert@sana.de
    - Principal Investigator:
      
      Sabine Mehnert, MD
  - Wolfratshausen, Germany, v
    - Completed
    - Praxis für Neurologie, Neurology
Switzerland
- - Luzern, Switzerland, 6000
    - Completed
    - Luzerner Kantonspital, Cardiology
  - Olten, Switzerland, 4500
    - Completed
    - Solothurner Spitäler AG, Bürgerspital Solothurn, Cardiology
  - Zug, Switzerland, 6300
    - Completed
    - Praxisgemeinschaft für Kardiologie, Innere Medizin und Psychosomatische Medizin, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

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

Description

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

• 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Participants at risk for hATTR and participants diagnosed with hATTR Participants 18 years of age or older

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analysis of prevalance of hATTR mutations among a cohort of participants at risk for hATTR. Time Frame: 4 years	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. Time Frame: 4 years	8 Follow up visits within 24 months	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establishment of biomarker/s in TTR positive cohort. Time Frame: 4 years	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CENTOGENE GmbH Rostock

Collaborators

Alnylam Pharmaceuticals

Investigators

Study Chair: Peter Bauer, Prof., CENTOGENE GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Centogene GmbH web page

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2017

Primary Completion (Estimated)

April 30, 2025

Study Completion (Estimated)

April 30, 2025

Study Registration Dates

First Submitted

July 31, 2017

First Submitted That Met QC Criteria

July 31, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

TRAM2 analysis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Cardiomyopathies

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