German Centre for Cardiovascular Research Cardiomyopathy Register

NCT ID: NCT02187263

Last Updated: 2016-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Myocarditis Dilated Cardiomyopathies Hypertrophic Cardiomyopathies Left Ventricular Myocardial Noncompaction Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathies Amyloidosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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hereditary DCM

No interventions assigned to this group

inflammatory DCM

No interventions assigned to this group

LVNC

No interventions assigned to this group

HCM

No interventions assigned to this group

ARVC

No interventions assigned to this group

acute myocarditis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kerckhoff Klinik

OTHER

Sponsor Role collaborator

University Hospital Goettingen

OTHER

Sponsor Role collaborator

University of Hamburg-Eppendorf

OTHER

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role collaborator

Mainz University

OTHER

Sponsor Role collaborator

University Medical Centre Mannheim

UNKNOWN

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Medical University of Hannover

OTHER

Sponsor Role collaborator

Department for Community Medicine, University Medicine Greifswald

UNKNOWN

Sponsor Role collaborator

Goethe University

OTHER

Sponsor Role collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role collaborator

University Hospital Greifswald

OTHER

Sponsor Role collaborator

German Heart Institute

OTHER

Sponsor Role collaborator

ISAR Klinikum Munich

INDUSTRY

Sponsor Role collaborator

Heidelberg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hugo A Katus, MD

Role: STUDY_CHAIR

Heidelberg University

Wolfgang Hoffmann, MD

Role: STUDY_CHAIR

Department for Community Medicine, University Medicine Greifswald

Locations

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University of Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Countries

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Germany

Facility Contacts

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Andreas O Doesch, MD

Role: primary

49 622156 ext. 39936

Other Identifiers

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DZHK TORCH 001

Identifier Type: -

Identifier Source: org_study_id

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