German Centre for Cardiovascular Research Cardiomyopathy Register

Brief Title

German Centre for Cardiovascular Research Cardiomyopathy Register

Official Title

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

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.
    

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 Type

Observational [Patient Registry]

Primary Outcome

Time to Disease Progression

Condition

Acute Myocarditis

Study Arms / Comparison Groups

 hereditary DCM

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Estimated Enrollment

2300

Start Date

December 2014

Completion Date

December 2017

Primary Completion Date

December 2016

Eligibility 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
      

Gender

All

Ages

18 Years - 79 Years

Accepts Healthy Volunteers

No

Contacts

Hugo A Katus, MD, , 

Location Countries

Germany

Location Countries

Germany

NCT ID

NCT02187263

Organization ID

DZHK TORCH 001

Responsible Party

Sponsor

Study Sponsor

Heidelberg University

Collaborators

 Kerckhoff Klinik

Study Sponsor

Hugo A Katus, MD, Study Chair, Heidelberg University

Verification Date

March 2016