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

Amyloidosis Clinical Trial

— TORCH-Plus  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04265040
• Other study ID #: TORCH-Plus DZHK21
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Amyloidosis
• Arrhythmogenic Right Ventricular Cardiomyopathy
• Arrhythmogenic Right Ventricular Dysplasia
• Cardiomyopathies
• Cardiomyopathy, Dilated
• Cardiomyopathy, Hypertrophic
• DCM - Dilated Cardiomyopathy
• HCM - Hypertrophic Cardiomyopathy
• HOCM - Hypertrophic Obstructive Cardiomyopathy
• Hypertrophy
• Inflammatory Cardiomyopathy
• Left Ventricular Noncompaction Cardiomyopathy
• Non-ischemic Cardiomyopathy

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