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

Sponsor

University Hospital Heidelberg (Other)

Overall Status

Recruiting

CT.gov ID

NCT04265040

Collaborator

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), University Hospital Frankfurt (Other), Universitätsklinikum Hamburg-Eppendorf (Other), University Medical Center Mainz (Other), University Medical Center Goettingen (Other), Deutsches Herzzentrum Muenchen (Other), Technische Universität München (Other), University Hospital Munich (Other), Kerckhoff Klinik (Other)

2,040

Enrollment

Location

87.4

Anticipated Duration (Months)

23.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Non-ischemic Cardiomyopathy DCM - Dilated Cardiomyopathy HCM - Hypertrophic Cardiomyopathy HOCM - Hypertrophic Obstructive Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Noncompaction Cardiomyopathy Amyloidosis Inflammatory Cardiomyopathy

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

2040 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)

Actual Study Start Date :

Aug 18, 2020

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Outcome Measures

Primary Outcome Measures

all-cause mortality [4 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)
Tachymyopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology	Heidelberg	Baden-Wuerttemberg	Germany	69120

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Benjamin Meder, Deputy Director - Clinic of Cardiology, Angiology and Pneumology, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT04265040

Other Study ID Numbers:

TORCH-Plus DZHK21

First Posted:

Feb 11, 2020

Last Update Posted:

May 18, 2022

Last Verified:

May 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Benjamin Meder, Deputy Director - Clinic of Cardiology, Angiology and Pneumology, University Hospital Heidelberg

Cardiomyopathies, registry, data, biomaterial, genetics

Additional relevant MeSH terms:

Cardiomyopathies

Cardiomyopathy, Hypertrophic

Cardiomyopathy, Dilated

Arrhythmogenic Right Ventricular Dysplasia

Amyloidosis

Hypertrophy

Study Results

No Results Posted as of May 18, 2022