Clinical trial NCT04265040: DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
Official title: TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-ischemic Cardiomyopathy
DCM - Dilated Cardiomyopathy
HCM - Hypertrophic Cardiomyopathy
HOCM - Hypertrophic Obstructive Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Left Ventricular Noncompaction Cardiomyopathy
Amyloidosis
Inflammatory Cardiomyopathy
Keywords: Cardiomyopathies, registry, data, biomaterial, genetics
Lead sponsor: University Hospital Heidelberg
Sponsor class: OTHER
Collaborators: name: University Medicine Greifswald
name: Charite University, Berlin, Germany
name: German Heart Center
name: University of Mannheim
name: University Hospital Schleswig-Holstein
name: Medical University of Hannover
name: Goethe University
name: Universitätsklinikum Hamburg-Eppendorf
name: University Medical Center Mainz
name: University Medical Center Goettingen
name: Deutsches Herzzentrum Muenchen
name: Technical University of Munich
name: University Hospital Munich
name: Kerckhoff Klinik
First posted: 2020-02-11
Enrollment: 2040
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

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.


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

Primary outcomes:
measure: all-cause mortality
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology
state: Baden-Wuerttemberg
Study officials:
References: