DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
NCT ID: NCT04265040
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2040 participants
OBSERVATIONAL
2020-08-18
2027-12-31
Brief Summary
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This DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. "Clinical phenotyping, follow-up \& biosampling" 2. "Genomics", 3. "Inflammation" and 4. "Biomarker". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 or ≤ 80 years
* The patient is able to understand the declaration of consent and to sign it dated
* At least one of the following diagnoses depending on the specific TORCH-
Plus inclusion / exclusion - SOP:
Dilated Cardiomyopathy (DCM)
* family / genetic
* inflammatory / persistent myocarditis
* idiopathic (after exclusion secondary cause)
* left sided systolic dysfunction (EF ≤ 45%)
Left ventricular hypertrophy
* sarcomere hypertrophic cardiomoypathia (HCM, HOCM)
* amyloid (AL: light chains, TTR: transthyretin, wild type)
Left ventricular non-compaction cardiomyopathy (LVNC)
Arrhythmogenic right ventricular cardiomyopathy (ARVC / D)
Exclusion Criteria
* Patient has other (cardiac) previous illnesses:
* uncontrollable arterial hypertension
* primary pulmonary arterial hypertension
* radiation therapy in the chest area
* addiction (drug or alcohol abuse)
* life expectancy \<1 year due to non-cardiological pre-existing conditions
* significant heart valve disease
* ischemic diseases and severe congenital heart diseases (including VSD, Fallot tetralogy, Ebstein anomaly)
* chemotoxic cardiomyopathy
* condition after myocarditis
* combination of several traditional risk factors (e.g. hypertension and diabetes mellitus)
* advanced chronic non-cardiac disease (e.g. chronic hepatitis or HIV)
* Tachymyopathy
18 Years
80 Years
ALL
No
Sponsors
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University Medicine Greifswald
OTHER
Charite University, Berlin, Germany
OTHER
German Heart Center
OTHER
University of Mannheim
OTHER
University Hospital Schleswig-Holstein
OTHER
Medical University of Hannover
OTHER
Goethe University
OTHER
Universitätsklinikum Hamburg-Eppendorf
OTHER
University Medical Center Mainz
OTHER
University Medical Center Goettingen
OTHER
Deutsches Herzzentrum Muenchen
OTHER
Technical University of Munich
OTHER
University Hospital Munich
OTHER
Kerckhoff Klinik
OTHER
University Hospital Heidelberg
OTHER
Responsible Party
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Benjamin Meder
Deputy Director - Clinic of Cardiology, Angiology and Pneumology
Locations
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University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Farbod Sedaghat-Hamedani, Dr.
Role: primary
Johannes Trebing, Dr.
Role: backup
Other Identifiers
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TORCH-Plus DZHK21
Identifier Type: -
Identifier Source: org_study_id