Clinical trial NCT02187263: German Centre for Cardiovascular Research Cardiomyopathy Register
Official title: DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocarditis
Dilated Cardiomyopathies
Hypertrophic Cardiomyopathies
Left Ventricular Myocardial Noncompaction Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathies
Amyloidosis
Keywords: hereditary cardiomyopathy,
inflammatory cardiomyopathy,
registry,
biomaterial,
clinical trial
Patients
Lead sponsor: Heidelberg University
Sponsor class: OTHER
Collaborators: name: Kerckhoff Klinik
name: University Hospital Goettingen
name: University of Hamburg-Eppendorf
name: University of Kiel
name: University of Luebeck
name: Mainz University
name: University Medical Centre Mannheim
name: Ludwig-Maximilians - University of Munich
name: Medical University of Hannover
name: Department for Community Medicine, University Medicine Greifswald
name: Goethe University
name: Charite University, Berlin, Germany
name: University Hospital Greifswald
name: German Heart Institute
name: ISAR Klinikum Munich
First posted: 2014-07-10
Enrollment: 2300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hereditary and inflammatory cardiomyopathies

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.

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

Primary outcomes:
measure: Time to Disease Progression
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University of Heidelberg
Study officials:
affiliation: Heidelberg University
name: Hugo A Katus, MD
role: STUDY_CHAIR
affiliation: Department for Community Medicine, University Medicine Greifswald
name: Wolfgang Hoffmann, MD
role: STUDY_CHAIR
References: