MyocarditisMYKKENCT02590341
Myocarditis Registry for Children and Adolescents - MYKKE
An observational study of Myocarditis, run by German Heart Institute at 13 sites in Germany.
Trial summary
MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Myocarditis
- How many people
- 1,500 participants
- Where
- 13 sitesGermany
- Study dates
- Jun 2014to May 2024
- How long will I take part?
- 10 Years
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients admitted to pediatric heart centers or pediatric cardiology departments
Who may be able to join
- Admission or referral diagnosis of myocarditis
- Age <18 years
- Written informed consent of the parents or legal guardians
Who cannot join
- Unwillingness to give consent
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Germany13 sites, 13 recruiting
- Recruiting
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
- Recruiting
Charite - Universitätsmedizin Berlin
Berlin, 13353
- Recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
- Recruiting
Klinikum Links der Weser
Bremen, 28277
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
- Recruiting
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Freiburg im Breisgau, 79106
- Recruiting
Universitätsklinikum Giessen und Marburg
Giessen, 35392
- Not yet recruiting
Universitätsmedizin Göttingen
Göttingen, 37099
- Recruiting
Universitäres Herzzentrum Hamburg
Hamburg, 20246
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
- Not yet recruiting
Universitätsklinikum Heidelberg
Heidelberg, 69120
- Recruiting
Universitätsklinikum des Saarlandes
Homburg, 66421
- Recruiting
Universitätsklinikum Schleswig-Holstein
Kiel, 24105
About this study
MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.
Read the detailed description
MYKKE is a long-term prospective registry providing a core platform for clinical research studies, which can be attached in a modular fashion. After a six-month pilot phase including 8 centers, the basic registry was opened in June 2014 to all hospitals in Germany treating patients with paediatric heart disease. While the scientific lead is with two study coordinators and a study group consisting of principal investigators from the collaborating centres ("MYKKE Investigators"), MYKKE is hosted and technically administered by the Competence Network for Congenital Heart Defects, which was initiated in 2003 by the Federal Ministry of Education and Research of the German government and is now part of the German Center for Cardiovascular Research (DZHK). Ethical approval was first obtained at the initiating centre (Deutsches Herzzentrum Berlin) and subsequently confirmed by local authorities of all collaborating centres.
The treating physicians enter basic data from patients enrolled at the study site via an online web interface to a central study database. For each patient, a specific patient identification number (PID) is generated based on name, first name and date of birth in order to store data in a pseudonymized fashion. As the PIDs are generated by a specific algorithm, data from the same patient are always linked to the same dataset even when data from different visits are entered by different institutions.
The web interface provides two different forms for each patient. The first form ("general sheet") is filled-in only at first presentation and consists of 12 items regarding disease and patient history, and initial symptoms of the disease. The second type of sheet ("current visit") can be generated once for each new patient visit and includes 52 items on characteristics of the current visit, current symptoms, diagnostic tests performed, confidence of the treating physician in the diagnosis on a subjective scale, left-ventricular function, therapy, complications, and follow-up care provider after discharge. Items primarily require yes/no responses via ticking respective boxes, allowing for completing each data sheet in <5 minutes when all data are available.
- Conditions
- Myocarditis
- Keywords
- myocarditis, children, adolescents, registry, multi-center, pediatric, heart failure, inflammatory heart disease, inflammatory cardiomyopathy
- Medical subject headings
- Myocarditis, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: one year
admission for heart failure
Measured: one year
major cardiovascular events
cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy
Measured: one year
Secondary outcomes (3)
systolic dysfunction
left ventricular ejection fraction <50%
Measured: one year
diastolic dysfunction
elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >= 50%
Measured: one year
impaired exercise tolerance
maximal oxygen uptake (VO2max) <5th percentile of normal
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (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 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
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- German Heart Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Competence Network for Congenital Heart Defects
- Responsible party
- Sponsor
- Investigators
- Daniel R Messroghli, MD, Study director, German Heart InstituteStephan N Schubert, MD, Study director, German Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590341
- Sponsor's protocol ID
- MYKKE Registry
- Acronym
- MYKKE
- Status last verified
- Oct 2015
- First submitted
- 8 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Seidel F, Nygren TM, Opgen-Rhein B, Hecht T, Boehne M, Weickmann J, Anderheiden F, Reineker K, Bocker D, Rentzsch A, Wiegand G, Fischer M, Kiski D, Frede W, Ruf B, Tarusinov G, Papakostas K, Logeswaran T, Schiebel A, Voges I, Kaestner M, Kramp J, Kerst G, Khedim M, Gatzweiler E, Wannenmacher B, Knirsch W, Meyer-Dobkowitz L, Donner B, Klingner J, Rau C, Haller S, Brinkmann A, Nitsche A, Noldt M, Schmoock G, Herzmann C, Degenhardt U, Buhler S, Enders M, Hermes J, Rolfs N, Manuylova T, Schwarzkopf E, Beudt J, Siffczyk C, Schubert S, Sandfort M, Klingel K. Severe Myocarditis Increase in Children Associated With Parvovirus B19 Infection: MYKKE Registry and German Surveillance Data. JACC Heart Fail. 2026 May;14(5):102854. doi: 10.1016/j.jchf.2025.102854. Epub 2026 Jan 5.
PubMed 41493405
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocarditis Registry for Children and Adolescents - MYKKE
- ClinicalTrials.gov ID
- NCT02590341
- Acronym / sponsor ID
- MYKKE / MYKKE Registry
- Conditions
- Myocarditis
- Keywords
- myocarditis, children, adolescents, registry, multi-center, pediatric, heart failure, inflammatory heart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- German Heart InstituteUniversity, hospital or other
- Collaborators
- Competence Network for Congenital Heart Defects
- Study start
- Jun 2014
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 29 Oct 2015 (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.
MYKKE is a prospective multi-center registry for children and adolescents with myocarditis. The aim is to generate prospective multi-center data on epidemiology, diagnostics, and therapy of pediatric patients with myocarditis in order to enable evidence-based diagnostic and therapeutic approaches for this myocardial disease.
Detailed description
MYKKE is a long-term prospective registry providing a core platform for clinical research studies, which can be attached in a modular fashion. After a six-month pilot phase including 8 centers, the basic registry was opened in June 2014 to all hospitals in Germany treating patients with paediatric heart disease. While the scientific lead is with two study coordinators and a study group consisting of principal investigators from the collaborating centres ("MYKKE Investigators"), MYKKE is hosted and technically administered by the Competence Network for Congenital Heart Defects, which was initiated in 2003 by the Federal Ministry of Education and Research of the German government and is now part of the German Center for Cardiovascular Research (DZHK). Ethical approval was first obtained at the initiating centre (Deutsches Herzzentrum Berlin) and subsequently confirmed by local authorities of all collaborating centres.
The treating physicians enter basic data from patients enrolled at the study site via an online web interface to a central study database. For each patient, a specific patient identification number (PID) is generated based on name, first name and date of birth in order to store data in a pseudonymized fashion. As the PIDs are generated by a specific algorithm, data from the same patient are always linked to the same dataset even when data from different visits are entered by different institutions.
The web interface provides two different forms for each patient. The first form ("general sheet") is filled-in only at first presentation and consists of 12 items regarding disease and patient history, and initial symptoms of the disease. The second type of sheet ("current visit") can be generated once for each new patient visit and includes 52 items on characteristics of the current visit, current symptoms, diagnostic tests performed, confidence of the treating physician in the diagnosis on a subjective scale, left-ventricular function, therapy, complications, and follow-up care provider after discharge. Items primarily require yes/no responses via ticking respective boxes, allowing for completing each data sheet in <5 minutes when all data are available.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients admitted to pediatric heart centers or pediatric cardiology departments
Key inclusion criteria (3 listed)
- Admission or referral diagnosis of myocarditis
- Age <18 years
- Written informed consent of the parents or legal guardians
Key exclusion criteria (1 listed)
- Unwillingness to give consent
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: one year
admission for heart failure
Time frame: one year
major cardiovascular events
Time frame: one year
cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy
3 secondary outcomes
systolic dysfunction
Time frame: one year
diastolic dysfunction
Time frame: one year
impaired exercise tolerance
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Derived from this study: PubMed 41493405Seidel F, Nygren TM, Opgen-Rhein B, Hecht T, Boehne M, Weickmann J, Anderheiden F, Reineker K, Bocker D, Rentzsch A, Wiegand G, Fischer M, Kiski D, Frede W, Ruf B, Tarusinov G, Papakostas K, Logeswaran T, Schiebel A, Voges I, Kaestner M, Kramp J, Kerst G, Khedim M, Gatzweiler E, Wannenmacher B, Knirsch W, Meyer-Dobkowitz L, Donner B, Klingner J, Rau C, Haller S, Brinkmann A, Nitsche A, Noldt M, Schmoock G, Herzmann C, Degenhardt U, Buhler S, Enders M, Hermes J, Rolfs N, Manuylova T, Schwarzkopf E, Beudt J, Siffczyk C, Schubert S, Sandfort M, Klingel K. Severe Myocarditis Increase in Children Associated With Parvovirus B19 Infection: MYKKE Registry and German Surveillance Data. JACC Heart Fail. 2026 May;14(5):102854. doi: 10.1016/j.jchf.2025.102854. Epub 2026 Jan 5.
- Website of MYKKE registry (German language only)Link provided by the sponsor.
Related trials for Myocarditis
Not yet recruitingObservational study
Monitoring and Rehabilitation for ICIACI Rehabilitation：A Cohort Study
Immune Checkpoint Inhibitor-Related Myocarditis
Recruiting
Baduanjin Rehabilitation for Functional Restoration in ICI-Associated Myocarditis
Immune Checkpoint Inhibitors Related Myocarditis
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
RecruitingObservational study
MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study
Myocarditis, Myocarditis Acute
Recruiting
Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients
Myocardial Infarction, Myocarditis Acute
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.
Daniel R Messroghli, MD study director
German Heart Institute
Stephan N Schubert, MD study director
German Heart Institute
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocarditis, run by German Heart Institute at 13 sites 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 3 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 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
Contact Thomas Pickardt, PhD (+49 30 4593 ext. 7279, pickardt@kompetenznetz-ahf.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: one year). The study lists 3 primary outcomes in all. 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 NCT02590341, 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 29 Oct 2015.