Clinical trial NCT02590341: Myocarditis Registry for Children and Adolescents - MYKKE
Official title: Myocarditis Registry for Children and Adolescents - MYKKE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocarditis
Keywords: myocarditis
children
adolescents
registry
multi-center
pediatric
heart failure
inflammatory heart disease
inflammatory cardiomyopathy
Lead sponsor: German Heart Institute
Sponsor class: OTHER
Collaborators: name: Competence Network for Congenital Heart Defects
First posted: 2015-10-29
Enrollment: 1500
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to pediatric heart centers or pediatric cardiology departments

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.

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.

Eligibility 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

Primary outcomes:
measure: all cause mortality
timeFrame: one year
measure: admission for heart failure
timeFrame: one year
measure: major cardiovascular events
timeFrame: one year
Secondary outcomes:
measure: systolic dysfunction
timeFrame: one year
measure: diastolic dysfunction
timeFrame: one year
measure: impaired exercise tolerance
timeFrame: one year
Other outcomes:
measure: medium-term all cause mortality
timeFrame: five years
measure: long-term all cause mortality
timeFrame: ten years
measure: medium-term admission for heart failure
timeFrame: five years
measure: long-term admission for heart failure
timeFrame: ten years
measure: medium-term major cardiovascular events
timeFrame: five years
measure: long-term major cardiovascular events
timeFrame: ten years
measure: medium-term systolic dysfunction
timeFrame: five years
measure: long-term systolic dysfunction
timeFrame: ten years
measure: medium-term diastolic dysfunction
timeFrame: five years
measure: long-term diastolic dysfunction
timeFrame: ten years
measure: medium-term impaired exercise tolerance
timeFrame: five years
measure: long-term impaired exercise tolerance
timeFrame: ten years
Locations:
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bremen
country: Germany
facility: Klinikum Links der Weser
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg - Bad Krozingen
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen und Marburg
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Homburg
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
Study officials:
affiliation: German Heart Institute
name: Daniel R Messroghli, MD
role: STUDY_DIRECTOR
affiliation: German Heart Institute
name: Stephan N Schubert, MD
role: STUDY_DIRECTOR
References: