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Myocarditis Registry for Children and Adolescents - MYKKE (MYKKE)

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ClinicalTrials.gov Identifier: NCT02590341
Recruitment Status : Recruiting
First Posted : October 29, 2015
Last Update Posted : October 29, 2015
Sponsor:
Collaborator:
Competence Network for Congenital Heart Defects
Information provided by (Responsible Party):
German Heart Institute

Brief 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 disease.

Condition or disease
Myocarditis

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 Type : Observational [Patient Registry]
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Myocarditis Registry for Children and Adolescents - MYKKE
Study Start Date : June 2014
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. all cause mortality [ Time Frame: one year ]
  2. admission for heart failure [ Time Frame: one year ]
  3. 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


Secondary Outcome Measures :
  1. systolic dysfunction [ Time Frame: one year ]
    left ventricular ejection fraction <50%

  2. diastolic dysfunction [ Time Frame: one year ]
    elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >= 50%

  3. impaired exercise tolerance [ Time Frame: one year ]
    maximal oxygen uptake (VO2max) <5th percentile of normal


Other Outcome Measures:
  1. medium-term all cause mortality [ Time Frame: five years ]
    mortality due to all causes at 5 years

  2. long-term all cause mortality [ Time Frame: ten years ]
    mortality due to all causes at 10 years

  3. medium-term admission for heart failure [ Time Frame: five years ]
    admission for heart failure at 5 years

  4. long-term admission for heart failure [ Time Frame: ten years ]
    admission for heart failure at 10 years

  5. medium-term major cardiovascular events [ Time Frame: five years ]
    major cardiovascular events at 5 years (cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy)

  6. long-term major cardiovascular events [ Time Frame: ten years ]
    major cardiovascular events at 10 years (cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy)

  7. medium-term systolic dysfunction [ Time Frame: five years ]
    left ventricular ejection fraction <50%

  8. long-term systolic dysfunction [ Time Frame: ten years ]
    left ventricular ejection fraction <50%

  9. medium-term diastolic dysfunction [ Time Frame: five years ]
    elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%

  10. long-term diastolic dysfunction [ Time Frame: ten years ]
    elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%

  11. medium-term impaired exercise tolerance [ Time Frame: five years ]
    maximal oxygen uptake (VO2max) <5th percentile of normal

  12. long-term impaired exercise tolerance [ Time Frame: ten years ]
    maximal oxygen uptake (VO2max) <5th percentile of normal



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients admitted to pediatric heart centers or pediatric cardiology departments
Criteria

Inclusion Criteria:

  • Admission or referral diagnosis of myocarditis
  • Age <18 years
  • Written informed consent of the parents or legal guardians

Exclusion Criteria:

  • Unwillingness to give consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590341


Contacts
Contact: Thomas Pickardt, PhD +49 30 4593 ext 7279 pickardt@kompetenznetz-ahf.de
Contact: Manuela Bauer +49 30 4593 ext 2879 mabauer@dhzb.de

Locations
Germany
Herz- und Diabeteszentrum NRW Recruiting
Bad Oeynhausen, Germany, 32545
Charite - Universitätsmedizin Berlin Recruiting
Berlin, Germany, 13353
Deutsches Herzzentrum Berlin Recruiting
Berlin, Germany, 13353
Klinikum Links der Weser Recruiting
Bremen, Germany, 28277
Universitätsklinikum Erlangen Recruiting
Erlangen, Germany, 91054
Universitäts-Herzzentrum Freiburg - Bad Krozingen Recruiting
Freiburg, Germany, 79106
Universitätsklinikum Giessen und Marburg Recruiting
Giessen, Germany, 35392
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany, 37099
Universitäres Herzzentrum Hamburg Recruiting
Hamburg, Germany, 20246
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Universitätsklinikum Heidelberg Not yet recruiting
Heidelberg, Germany, 69120
Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66421
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Sponsors and Collaborators
German Heart Institute
Competence Network for Congenital Heart Defects
Investigators
Study Director: Daniel R Messroghli, MD German Heart Institute
Study Director: Stephan N Schubert, MD German Heart Institute

Additional Information:
Responsible Party: German Heart Institute
ClinicalTrials.gov Identifier: NCT02590341     History of Changes
Other Study ID Numbers: MYKKE Registry
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 29, 2015
Last Verified: October 2015

Keywords provided by German Heart Institute:
myocarditis
children
adolescents
registry
multi-center
pediatric
heart failure
inflammatory heart disease
inflammatory cardiomyopathy

Additional relevant MeSH terms:
Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases