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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyloidosis; HCM - Hypertrophic Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy; Inflammatory Cardiomyopathy; DCM - Dilated Cardiomyopathy; Non-ischemic Cardiomyopathy; HOCM - Hypertrophic Obstructive Cardiomyopathy; Left Ventricular Noncompaction Cardiomyopathy

• Study Type: Observational
• Enrollment (Estimated): 2040

Contacts and Locations

• Study Contact: Name: Farbod Sedaghat-Hamendani, Dr.; Phone Number: +496221/56-8676; Email: Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de
• Study Contact Backup: Name: Johannes Trebing, Dr.; Email: Johannes.Trebing@med.uni-heidelberg.de

Study Locations

• Germany
  • Baden-Wuerttemberg
    • Heidelberg, Baden-Wuerttemberg, Germany, 69120
      • Recruiting
      • University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology
      • Contact: Johannes Trebing, Dr.; Email: Johannes.Trebing@med.uni-heidelberg.de
      • Contact: Farbod Sedaghat-Hamedani, Dr.; Phone Number: +496221568676; Email: Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality	4 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2020
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: February 7, 2020
• First Submitted That Met QC Criteria: February 10, 2020
• First Posted (Actual): February 11, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cardiomyopathies, registry, data, biomaterial, genetics
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Proteostasis Deficiencies; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiomegaly; Laminopathies; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Amyloidosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic; Arrhythmogenic Right Ventricular Dysplasia
• Other Study ID Numbers: TORCH-Plus DZHK21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No