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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265040
Other study ID # TORCH-Plus DZHK21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 18, 2020
Est. completion date December 2027

Study information

Verified date November 2023
Source University Hospital Heidelberg
Contact Farbod Sedaghat-Hamendani, Dr.
Phone +496221/56-8676
Email Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2040
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
Germany University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology Heidelberg Baden-Wuerttemberg

Sponsors (15)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary all-cause mortality 4 years
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