NCT04265040 DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
| NCT ID | NCT04265040 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital Heidelberg |
| Condition | Non-ischemic Cardiomyopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,040 participants |
| Start Date | 2020-08-18 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,040 participants in total. It began in 2020-08-18 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04265040 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Non-ischemic Cardiomyopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04265040 currently recruiting?
Yes, NCT04265040 is actively recruiting participants. Contact the research team at Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de for enrollment information.
Where is the NCT04265040 trial being conducted?
This trial is being conducted at Heidelberg, Germany.
Who is sponsoring the NCT04265040 clinical trial?
NCT04265040 is sponsored by University Hospital Heidelberg. The trial plans to enroll 2,040 participants.