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

Recruiting

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

• Registration Number: NCT04265040
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-10
• Study First Posted: 2020-02-11
• Study Start: 2020-08-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-11-30
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2040

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all-cause mortality	4 years

Trial Locations

Locations (1)

University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany