TORCH: German Centre for Cardiovascular Research Cardiomyopathy Register

Sponsor

Heidelberg University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02187263

Collaborator

Kerckhoff Klinik (Other), University Hospital Goettingen (Other), University of Hamburg-Eppendorf (Other), University of Kiel (Other), University of Luebeck (Other), Mainz University (Other), University Medical Centre Mannheim (Other), Ludwig-Maximilians - University of Munich (Other), Medical University of Hannover (Other), Department for Community Medicine, University Medicine Greifswald (Other), University Hospital Frankfurt (Other), Charite University, Berlin, Germany (Other), University Hospital Greifswald (Other), German Heart Institute (Other), University Hospital Klinikum Rechts der Isar Munich (Other)

2,300

Enrollment

Location

Duration (Months)

63.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a joint project by Heidelberg University and Greifswald University.

Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as:

central hub for clinical outcome studies.
joint resource for diagnostic and therapeutic trials.
common biomaterial bank.
resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.

Condition or Disease	Intervention/Treatment	Phase
Acute Myocarditis Dilated Cardiomyopathies Hypertrophic Cardiomyopathies Left Ventricular Myocardial Noncompaction Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathies Amyloidosis

Detailed Description

The following basic research projects, called modules, will be tied to and rely on the recruitment of CMP patients and the infrastructure provided by TORCH:

Well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact.
Functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems.
The integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary CMP.
By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level.

The registry will also facilitate investigator initiated clinical trials.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)

Study Start Date :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
hereditary DCM
inflammatory DCM
LVNC
HCM
ARVC
acute myocarditis

Outcome Measures

Primary Outcome Measures

Time to Disease Progression [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis.

Exclusion Criteria:

Preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; Severe arterial hypertension; Primary pulmonary artery hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents and chest radiation; Drug and alcohol abuse; Patients <18 and >79 years of age; Life expectancy less than 1 year due to non-cardiac comorbidity

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Heidelberg	Heidelberg		Germany

Sponsors and Collaborators

Heidelberg University
Kerckhoff Klinik
University Hospital Goettingen
University of Hamburg-Eppendorf
University of Kiel
University of Luebeck
Mainz University
University Medical Centre Mannheim
Ludwig-Maximilians - University of Munich
Medical University of Hannover
Department for Community Medicine, University Medicine Greifswald
University Hospital Frankfurt
Charite University, Berlin, Germany
University Hospital Greifswald
German Heart Institute
University Hospital Klinikum Rechts der Isar Munich

Investigators

Study Chair: Hugo A Katus, MD, Heidelberg University
Study Chair: Wolfgang Hoffmann, MD, Department for Community Medicine, University Medicine Greifswald