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Recruiting NCT04265040

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

— Observational Non-ischemic Cardiomyopathy DCM - Dilated Cardiomyopathy HCM - Hypertrophic Cardiomyopathy HOCM - Hypertrophic Obstructive Cardiomyopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy, HOCM - Hypertrophic Obstructive Cardiomyopathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • all-cause mortality [Time frame: 4 years]

Eligibility 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)
  • Tachymyopathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 1 center
  • University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology — Heidelberg

Identifiers

NCT: NCT04265040 · TORCH-Plus DZHK21

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗