Acute MyocarditisTORCHNCT02187263
German Centre for Cardiovascular Research Cardiomyopathy Register
An observational study of Acute Myocarditis and Dilated Cardiomyopathies, run by Heidelberg University at 1 site in Germany.
Trial summary
This is a joint project by Heidelberg University and Greifswald University. Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as: 1. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Acute Myocarditis, Dilated Cardiomyopathies, Hypertrophic Cardiomyopathies
- How many people
- 2,300 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2014to Dec 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hereditary and inflammatory cardiomyopathies
Who may be able to join
- Patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis.
Who cannot join
- Preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; Severe arterial hypertension; Primary pulmonary artery hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents and chest radiation; Drug and alcohol abuse; Patients <18 and >79 years of age; Life expectancy less than 1 year due to non-cardiac comorbidity
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Heidelberg
Heidelberg
Andreas O Doesch, MD, 49 622156 ext. 39936, Andreas.Doesch@med.uni-heidelberg.de
About this study
Official title: DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
This is a joint project by Heidelberg University and Greifswald University.
Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as:
- central hub for clinical outcome studies.
- joint resource for diagnostic and therapeutic trials.
- common biomaterial bank.
- resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.
Read the detailed description
The following basic research projects, called modules, will be tied to and rely on the recruitment of CMP patients and the infrastructure provided by TORCH:
- Well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact.
- Functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems.
- The integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary CMP.
- By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level.
The registry will also facilitate investigator initiated clinical trials.
- Conditions
- Acute Myocarditis, Dilated Cardiomyopathies, Hypertrophic Cardiomyopathies, Left Ventricular Myocardial Noncompaction Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathies, Amyloidosis
- Keywords
- hereditary cardiomyopathy,, inflammatory cardiomyopathy,, registry,, biomaterial,, clinical trial, Patients
- Medical subject headings
- Cardiomyopathy, Dilated, Cardiomyopathy, Hypertrophic, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hereditary DCM | Not described | |
| inflammatory DCM | Not described | |
| LVNC | Not described | |
| HCM | Not described | |
| ARVC | Not described | |
| acute myocarditis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disease Progression
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (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 Acute MyocarditisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,300 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- Kerckhoff Klinik, University Hospital Goettingen, University of Hamburg-Eppendorf, University of Kiel, University of Luebeck, Mainz University, University Medical Centre Mannheim, Ludwig-Maximilians - University of Munich, Medical University of Hannover, Department for Community Medicine, University Medicine Greifswald, Goethe University, Charite University, Berlin, Germany, University Hospital Greifswald, German Heart Institute, ISAR Klinikum Munich
- Responsible party
- Sponsor
- Investigators
- Hugo A Katus, MD, Study chair, Heidelberg UniversityWolfgang Hoffmann, MD, Study chair, Department for Community Medicine, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02187263
- Sponsor's protocol ID
- DZHK TORCH 001
- Acronym
- TORCH
- Status last verified
- Mar 2016
- First submitted
- 8 Jul 2014
- Last updated
- 25 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
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 25 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DZHK TranslatiOnal Registry for CardiomyopatHies Deutsches Zentrum für Herz- Und Kreislauf-Forschung (DZHK)
- ClinicalTrials.gov ID
- NCT02187263
- Acronym / sponsor ID
- TORCH / DZHK TORCH 001
- Conditions
- Acute Myocarditis, Dilated Cardiomyopathies, Hypertrophic Cardiomyopathies, Left Ventricular Myocardial Noncompaction Cardiomyopathy, Arrhythmogenic Right Ventricular Cardiomyopathies, Amyloidosis
- Keywords
- hereditary cardiomyopathy,, inflammatory cardiomyopathy,, registry,, biomaterial,, clinical trial, Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,300 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- Kerckhoff Klinik, University Hospital Goettingen, University of Hamburg-Eppendorf, University of Kiel, University of Luebeck, Mainz University, University Medical Centre Mannheim, Ludwig-Maximilians - University of Munich, Medical University of Hannover, Department for Community Medicine, University Medicine Greifswald, Goethe University, Charite University, Berlin, Germany, University Hospital Greifswald, German Heart Institute, ISAR Klinikum Munich
- Study start
- Dec 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- 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.
This is a joint project by Heidelberg University and Greifswald University.
Our objective is to establish an unique national multi-center registry and biobank of well phenotyped patients with non-ischemic cardiomyopathies (CMP) including in depth clinical, molecular and omics-based phenotyping to serve as:
- central hub for clinical outcome studies.
- joint resource for diagnostic and therapeutic trials.
- common biomaterial bank.
- resource for detailed molecular analyses on patients' biomaterials and patient specific model systems.
Detailed description
The following basic research projects, called modules, will be tied to and rely on the recruitment of CMP patients and the infrastructure provided by TORCH:
- Well phenotyped patients will be the starting point for comprehensive next-generation genotyping, leading to advanced estimates of genotype-phenotype relationship and its clinical impact.
- Functional analysis of novel genomic loci and their related molecular pathways will be based on our established in-vitro (e.g. iPS cells, yeast two hybrid) and in-vivo (e.g. zebrafish and mice) model systems.
- The integrated analysis of viral load and replication, inflammation, genotype and clinical variables will define risk variables for inflammatory and hereditary CMP.
- By longitudinal follow-up of patients, the role of genetic, epigenetic, metabolic, molecular biomarkers and histopathology for diagnosis and out-come prediction will be defined on a national level.
The registry will also facilitate investigator initiated clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| hereditary DCM | – | – |
| inflammatory DCM | – | – |
| LVNC | – | – |
| HCM | – | – |
| ARVC | – | – |
| acute myocarditis | – | – |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hereditary and inflammatory cardiomyopathies
Key inclusion criteria (1 listed)
- Patients with primary non-ischemic cardiomyopathies including hereditary and inflammatory dilated cardiomyopathy, left ventricular non-compaction cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and acute myocarditis.
Key exclusion criteria (1 listed)
- Preexisting other cardiac diseases such as significant valvular, ischemic or pericardial disease; Severe arterial hypertension; Primary pulmonary artery hypertension; Chronic advanced disorders; History of treatment with cardiotoxic agents and chest radiation; Drug and alcohol abuse; Patients <18 and >79 years of age; Life expectancy less than 1 year due to non-cardiac comorbidity
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
Time to Disease Progression
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2016.
- 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. This study is not recruiting at the moment.
Hugo A Katus, MD study chair
Heidelberg University
Wolfgang Hoffmann, MD study chair
Department for Community Medicine, University Medicine Greifswald
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 Acute Myocarditis and Dilated Cardiomyopathies, run by Heidelberg University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 25 Mar 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Disease Progression (time frame: 12 months). 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 NCT02187263, 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 25 Mar 2016.