- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187263
German Centre for Cardiovascular Research Cardiomyopathy Register (TORCH)
DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
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:
- central hub for clinical outcome studies.
- joint resource for diagnostic and therapeutic trials.
- common biomaterial bank.
- resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Heidelberg, Germany
- Recruiting
- University of Heidelberg
-
Contact:
- Andreas O Doesch, MD
- Phone Number: 39936 49 622156
- Email: Andreas.Doesch@med.uni-heidelberg.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
hereditary DCM
|
inflammatory DCM
|
LVNC
|
HCM
|
ARVC
|
acute myocarditis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Disease Progression
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Hugo A Katus, MD, Heidelberg University
- Study Chair: Wolfgang Hoffmann, MD, Department for Community Medicine, University Medicine Greifswald
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Aortic Valve Disease
- Heart Valve Diseases
- Proteostasis Deficiencies
- Heart Defects, Congenital
- Cardiovascular Abnormalities
- Cardiomegaly
- Laminopathies
- Aortic Stenosis, Subvalvular
- Aortic Valve Stenosis
- Amyloidosis
- Myocarditis
- Cardiomyopathies
- Cardiomyopathy, Dilated
- Cardiomyopathy, Hypertrophic
- Arrhythmogenic Right Ventricular Dysplasia
Other Study ID Numbers
- DZHK TORCH 001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Amyloidosis
-
Millennium Pharmaceuticals, Inc.CompletedLight-Chain AmyloidosisUnited States, Canada, France, Germany, Italy
-
Boston UniversityCorino Therapeutics, Inc.CompletedTransthyretin Amyloidosis | Amyloidosis, Leptomeningeal, Transthyretin-RelatedUnited States
-
Chulalongkorn UniversityUnknown
-
Criterium, Inc.AmgenCompletedAmyloidosis | Systemic Light Chain AmyloidosisUnited States
-
Steen Hvitfeldt PoulsenRecruitingTransthyretin Amyloidosis | Transthyretin Cardiac Amyloidosis | Wild-Type Transthyretin-Related (ATTR)AmyloidosisDenmark
-
Peking Union Medical College HospitalXian-Janssen Pharmaceutical Ltd.Active, not recruitingAmyloidosis; SystemicChina
-
IRCCS Policlinico S. MatteoRecruiting
-
University Hospital Center of MartiniqueTerminated
-
Kaneka Medical America LLCRecruitingDialysis AmyloidosisUnited States
-
Peking Union Medical College HospitalRecruitingLight Chain (AL) Amyloidosis | Venetoclax | CCND1 TranslocationChina