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NCT Number: NCT04265040

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

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.

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Key information

Conditions

Non-ischemic Cardiomyopathy Amyloidosis Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmogenic Right Ventricular Cardiomyopathy Arrhythmogenic Right Ventricular Dysplasia Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiomyopathy, Hypertrophic Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities DCM - Dilated Cardiomyopathy Genetic Diseases, Inborn HCM - Hypertrophic Cardiomyopathy HOCM - Hypertrophic Obstructive Cardiomyopathy Heart Defects, Congenital Heart Diseases Heart Valve Diseases Inflammatory Cardiomyopathy Laminopathies Left Ventricular Noncompaction Cardiomyopathy Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location status: Recruiting

Location contact

Farbod Sedaghat-Hamedani, Dr.

CONTACT

[email protected]

+496221568676

Johannes Trebing, Dr.

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

all-cause mortality

Time frame: 4 years

Study contacts

Contact information is provided by the study sponsor or research team.

Farbod Sedaghat-Hamendani, Dr.

CONTACT

[email protected]

+496221/56-8676

Johannes Trebing, Dr.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital Heidelberg

Other

Collaborators

Charite University, Berlin, Germany
Deutsches Herzzentrum Muenchen
German Heart Center
Goethe University
Kerckhoff Klinik
Medical University of Hannover
Technical University of Munich
University Hospital Munich
University Hospital Schleswig-Holstein
University Medical Center Goettingen
University Medical Center Mainz
University Medicine Greifswald
University of Mannheim
Universitätsklinikum Hamburg-Eppendorf

Registry information

Official study title

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

Acronym: TORCH-Plus

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Feb 11, 2020
Registry last updated: Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting