Myocarditis Registry for Children and Adolescents - MYKKE

• Conditions: Myocarditis

• Registration Number: NCT02590341
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-06
• Status Verified: 2015-10
• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-27
• Last Update Submitted: 2015-10-27
• Study First Posted: 2015-10-29
• Last Update Posted: 2015-10-29
• Primary Completion: 2024-05
• Study Completion: 2024-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
all cause mortality	one year
admission for heart failure	one year
major cardiovascular events	one year	cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy

Secondary Outcome Measures

Name	Time	Method
systolic dysfunction	one year	left ventricular ejection fraction \<50%
diastolic dysfunction	one year	elevated natriuretic peptides, E/E' \>15, left ventricular ejection fraction \>= 50%
impaired exercise tolerance	one year	maximal oxygen uptake (VO2max) \<5th percentile of normal

Trial Locations

Locations (13)

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Klinikum Links der Weser; 🇩🇪 Bremen, Germany

Universitäts-Herzzentrum Freiburg - Bad Krozingen; 🇩🇪 Freiburg, Germany

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Universitäres Herzzentrum Hamburg; 🇩🇪 Hamburg, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Charite - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

Universitätsklinikum Schleswig-Holstein; 🇩🇪 Kiel, Germany

Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Giessen und Marburg; 🇩🇪 Giessen, Germany