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

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Brief Title

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)

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.
    



Study Type

Observational [Patient Registry]


Primary Outcome

all-cause mortality


Condition

Non-ischemic Cardiomyopathy



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

2040

Start Date

April 2020

Completion Date

December 2027

Primary Completion Date

December 2027

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)

               -  Tachymyopathie
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

, , 



Administrative Informations


NCT ID

NCT04265040

Organization ID

TORCH-Plus DZHK21


Responsible Party

Principal Investigator

Study Sponsor

University Hospital Heidelberg

Collaborators

 University Medicine Greifswald

Study Sponsor

, , 


Verification Date

February 2020