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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02187263
Other study ID # DZHK TORCH 001
Secondary ID
Status Recruiting
Phase N/A
First received July 8, 2014
Last updated March 24, 2016
Start date December 2014
Est. completion date December 2017

Study information

Verified date March 2016
Source Heidelberg University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2300
Est. completion date December 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 79 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University of Heidelberg Heidelberg

Sponsors (16)

Lead Sponsor Collaborator
Heidelberg University Charite University, Berlin, Germany, Department for Community Medicine, University Medicine Greifswald, German Heart Institute Berlin, Kerckhoff Klinik, Ludwig-Maximilians - University of Munich, Mainz University, Medical University of Hannover, University Hospital Goettingen, University Hospital Greifswald, University Hospital Klinikum Rechts der Isar Munich, University Hospital, Frankfurt, University Medical Centre Mannheim, University of Hamburg, University of Kiel, University of Luebeck

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Disease Progression 12 months No
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