Non-ischemic CardiomyopathyTORCH-PlusNCT04265040
DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies
An observational study of Non-ischemic Cardiomyopathy and DCM - Dilated Cardiomyopathy, run by University Hospital Heidelberg at 1 site in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy
- How many people
- 2,040 participants
- Where
- 1 siteGermany
- Study dates
- 18 Aug 2020to Dec 2027
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- 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)
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Johannes Trebing, Dr. contact
Germany1 site, 1 recruiting
- Recruiting
University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology
Heidelberg, Baden-Wurttemberg, 69120
Farbod Sedaghat-Hamedani, Dr., +496221568676, Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de
Johannes Trebing, Dr., Johannes.Trebing@med.uni-heidelberg.de
About this study
Official title: TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)
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.
- Conditions
- Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy, HOCM - Hypertrophic Obstructive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Noncompaction Cardiomyopathy
- Keywords
- Cardiomyopathies, registry, data, biomaterial, genetics
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Arrhythmogenic Right Ventricular Dysplasia, Amyloidosis, Cardiomyopathies
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start18 Aug 2020
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-ischemic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by University Hospital HeidelbergThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,040 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- University Medicine Greifswald, Charite University, Berlin, Germany, German Heart Center, University of Mannheim, University Hospital Schleswig-Holstein, Medical University of Hannover, Goethe University, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Mainz, University Medical Center Goettingen, Deutsches Herzzentrum Muenchen, Technical University of Munich, University Hospital Munich, Kerckhoff Klinik
- Responsible party
- Principal investigator, Benjamin Meder, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265040
- Sponsor's protocol ID
- TORCH-Plus DZHK21
- Acronym
- TORCH-Plus
- Status last verified
- Nov 2023
- First submitted
- 7 Feb 2020
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Suwalski P, Golpour A, Weiner J 3rd, Musigk N, Balzer F, Giesa N, Amr A, Zyla J, Ganz P, Saleem HN, Trebing J, Sedaghat-Hamedani F, Meder B, Gold SM, Ebert A, Beule D, Landmesser U, Heidecker B. Cytokine-associated ROS and Ca2+ dysregulation in severe inflammatory cardiomyopathy. Cardiovasc Res. 2026 Aug 30:cvag099. doi: 10.1093/cvr/cvag099. Online ahead of print.
PubMed 42669063
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TranslatiOnal Registry for CardiomyopatHies (TORCH) - Plus as Part of the German Centre for Cardiovascular Research (DZHK)
- ClinicalTrials.gov ID
- NCT04265040
- Acronym / sponsor ID
- TORCH-Plus / TORCH-Plus DZHK21
- Conditions
- Non-ischemic Cardiomyopathy, DCM - Dilated Cardiomyopathy, HCM - Hypertrophic Cardiomyopathy, HOCM - Hypertrophic Obstructive Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathy, Left Ventricular Noncompaction Cardiomyopathy
- Keywords
- Cardiomyopathies, registry, data, biomaterial, genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,040 participants (estimated)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- University Medicine Greifswald, Charite University, Berlin, Germany, German Heart Center, University of Mannheim, University Hospital Schleswig-Holstein, Medical University of Hannover, Goethe University, Universitätsklinikum Hamburg-Eppendorf, University Medical Center Mainz, University Medical Center Goettingen, Deutsches Herzzentrum Muenchen, Technical University of Munich, University Hospital Munich, Kerckhoff Klinik
- Study start
- 18 Aug 2020 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (15 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all-cause mortality
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Derived from this study: PubMed 42669063Suwalski P, Golpour A, Weiner J 3rd, Musigk N, Balzer F, Giesa N, Amr A, Zyla J, Ganz P, Saleem HN, Trebing J, Sedaghat-Hamedani F, Meder B, Gold SM, Ebert A, Beule D, Landmesser U, Heidecker B. Cytokine-associated ROS and Ca2+ dysregulation in severe inflammatory cardiomyopathy. Cardiovasc Res. 2026 Aug 30:cvag099. doi: 10.1093/cvr/cvag099. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johannes Trebing, Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-ischemic Cardiomyopathy and DCM - Dilated Cardiomyopathy, run by University Hospital Heidelberg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Farbod Sedaghat-Hamendani, Dr. (+496221/56-8676, Farbod.Sedaghat-Hamedani@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04265040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.