German Centre for Cardiovascular Research Cardiomyopathy Register

NCT02187263 | Unknown DMC

• 1 other identifier: DZHK TORCH 001
• Study Type: observational
• Target: 2,300
• Locations: 1 country
• Sites: 1

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. 1.central hub for clinical outcome studies.
2. 2.joint resource for diagnostic and therapeutic trials.
3. 3.common biomaterial bank.
4. 4.resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.

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

Outcome Measures

Primary Outcomes (1)

• Time to Disease Progression

  12 months

Study Arms (6)

hereditary DCM

inflammatory DCM

LVNC

HCM

ARVC

acute myocarditis

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hereditary and inflammatory cardiomyopathies

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead
• Kerckhoff Klinik: collaborator
• University Hospital Goettingen: collaborator
• University of Hamburg-Eppendorf: collaborator
• University of Kiel: collaborator
• University of Luebeck: collaborator
• Mainz University: collaborator
• University Medical Centre Mannheim: collaborator
• Ludwig-Maximilians - University of Munich: collaborator
• Medical University of Hannover: collaborator
• Department for Community Medicine, University Medicine Greifswald: collaborator
• Goethe University: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital Greifswald: collaborator
• German Heart Institute: collaborator
• ISAR Klinikum Munich: collaborator

Study Sites (1)

University of Heidelberg

Heidelberg, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EDTA, serum, urine

MeSH Terms

Conditions

Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Amyloidosis

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Cardiovascular Diseases; Cardiomyopathies; Laminopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hugo A Katus, MD

  Heidelberg University

  STUDY CHAIR

• Wolfgang Hoffmann, MD

  Department for Community Medicine, University Medicine Greifswald

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2014
• First Posted: July 10, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

DE (1)