German Centre for Cardiovascular Research Cardiomyopathy Register

Amyloidosis Clinical Trial

— TORCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187263
• Other study ID #: DZHK TORCH 001
• 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

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

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