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NCT04265040Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 30 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
2040 (estimated)
First submitted
7 Feb 2020
Start date
18 Aug 2020
Primary completion date
Dec 2027
Lead sponsor
University Hospital Heidelberg
NCT number
NCT04265040

What you commit to

  • Study type: Observational
  • Planned participants: 2040
  • From 18 Aug 2020 to the primary completion date, Dec 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Age: \<18 years or\> 80 years

Other

  • The following exclusion criteria have been defined and must be taken from the TORCH-Plus specific inclusion / exclusion - SOP in detail:

Who the study is looking for

  • 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)

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology
Coordinator of this site? Confirm its status
HeidelbergGermanyRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.