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.
Recruitment Information
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
Administrative Informations
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