NCT04265040

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,040

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Aug 2020Dec 2027

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

August 18, 2020

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

7.3 years

First QC Date

February 7, 2020

Last Update Submit

November 29, 2023

Conditions

Keywords

Cardiomyopathies, registry, data, biomaterial, genetics

Outcome Measures

Primary Outcomes (1)

  • all-cause mortality

    4 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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-
  • Dilated Cardiomyopathy (DCM)
  • family / genetic
  • inflammatory / persistent myocarditis
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology

Heidelberg, Baden-Wurttemberg, 69120, Germany

RECRUITING

MeSH Terms

Conditions

Cardiomyopathy, DilatedCardiomyopathy, HypertrophicArrhythmogenic Right Ventricular DysplasiaAmyloidosisCardiomyopathies

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCongenital AbnormalitiesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director - Clinic of Cardiology, Angiology and Pneumology

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

August 18, 2020

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

November 30, 2023

Record last verified: 2023-11

Locations