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TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies (TORCH-Plus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04265040
Recruitment Status : Not yet recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Sponsor:
Collaborators:
University Medicine Greifswald
Charite University, Berlin, Germany
German Heart Center
University of Mannheim
University Hospital Schleswig-Holstein
Medical University of Hannover
University Hospital, Frankfurt
Universitätsklinikum Hamburg-Eppendorf
University Medical Center Mainz
University Medical Center Goettingen
Deutsches Herzzentrum Muenchen
Technische Universität München
University Hospital Munich
Kerckhoff Klinik
Information provided by (Responsible Party):
Benjamin Meder, University Hospital Heidelberg

Brief Summary:

The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity.

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.


Condition or disease
Non-ischemic Cardiomyopathy DCM - Dilated Cardiomyopathy HCM - Hypertrophic Cardiomyopathy HOCM - Hypertrophic Obstructive Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Noncompaction Cardiomyopathy Amyloidosis Inflammatory Cardiomyopathy

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2040 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027





Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 4 years ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Non-ischemic structural cardiomyopathies
  • 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:

The following exclusion criteria have been defined and must be taken from the TORCH-Plus specific inclusion / exclusion - SOP in detail:

  • Age: <18 years or> 80 years
  • 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)
    • Tachymyopathie
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Responsible Party: Benjamin Meder, Prof. Dr. med., University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT04265040    
Other Study ID Numbers: TORCH-Plus DZHK21
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benjamin Meder, University Hospital Heidelberg:
Cardiomyopathies, registry, data, biomaterial, genetics
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Arrhythmogenic Right Ventricular Dysplasia
Amyloidosis
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities