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German Centre for Cardiovascular Research Cardiomyopathy Register (TORCH)

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ClinicalTrials.gov Identifier: NCT02187263
Recruitment Status : Unknown
Verified March 2016 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : July 10, 2014
Last Update Posted : March 25, 2016
Sponsor:
Collaborators:
Kerckhoff Klinik
University Hospital Goettingen
University of Hamburg
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
Information provided by (Responsible Party):
Heidelberg University

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:

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

Condition or disease
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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017


Group/Cohort
hereditary DCM
inflammatory DCM
LVNC
HCM
ARVC
acute myocarditis



Primary Outcome Measures :
  1. Time to Disease Progression [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
EDTA, serum, urine


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hereditary and inflammatory cardiomyopathies
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187263


Locations
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Germany
University of Heidelberg Recruiting
Heidelberg, Germany
Contact: Andreas O Doesch, MD    49 622156 ext 39936    Andreas.Doesch@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Kerckhoff Klinik
University Hospital Goettingen
University of Hamburg
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
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Study Chair: Hugo A Katus, MD Heidelberg University
Study Chair: Wolfgang Hoffmann, MD Department for Community Medicine, University Medicine Greifswald

Additional Information:

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Responsible Party: Heidelberg University
ClinicalTrials.gov Identifier: NCT02187263     History of Changes
Other Study ID Numbers: DZHK TORCH 001
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016
Keywords provided by Heidelberg University:
hereditary cardiomyopathy,
inflammatory cardiomyopathy,
registry,
biomaterial,
clinical trial
Patients
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Myocarditis
Arrhythmogenic Right Ventricular Dysplasia
Amyloidosis
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities