Myocarditis Registry for Children and Adolescents - MYKKE

Sponsor

German Heart Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT02590341

Collaborator

Competence Network for Congenital Heart Defects (Other)

1,500

Enrollment

Locations

119

Duration (Months)

115.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Myocarditis Registry for Children and Adolescents - MYKKE

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

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

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

Other Outcome Measures

medium-term all cause mortality [five years]
mortality due to all causes at 5 years
long-term all cause mortality [ten years]
mortality due to all causes at 10 years
medium-term admission for heart failure [five years]
admission for heart failure at 5 years
long-term admission for heart failure [ten years]
admission for heart failure at 10 years
medium-term major cardiovascular events [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)
long-term major cardiovascular events [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)
medium-term systolic dysfunction [five years]
left ventricular ejection fraction <50%
long-term systolic dysfunction [ten years]
left ventricular ejection fraction <50%
medium-term diastolic dysfunction [five years]
elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%
long-term diastolic dysfunction [ten years]
elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%
medium-term impaired exercise tolerance [five years]
maximal oxygen uptake (VO2max) <5th percentile of normal
long-term impaired exercise tolerance [ten years]
maximal oxygen uptake (VO2max) <5th percentile of normal

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Herz- und Diabeteszentrum NRW	Bad Oeynhausen	Germany	32545
2	Charite - Universitätsmedizin Berlin	Berlin	Germany	13353
3	Deutsches Herzzentrum Berlin	Berlin	Germany	13353
4	Klinikum Links der Weser	Bremen	Germany	28277
5	Universitätsklinikum Erlangen	Erlangen	Germany	91054
6	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Freiburg	Germany	79106
7	Universitätsklinikum Giessen und Marburg	Giessen	Germany	35392
8	Universitätsmedizin Göttingen	Göttingen	Germany	37099
9	Universitäres Herzzentrum Hamburg	Hamburg	Germany	20246
10	Medizinische Hochschule Hannover	Hannover	Germany	30625
11	Universitätsklinikum Heidelberg	Heidelberg	Germany	69120
12	Universitätsklinikum des Saarlandes	Homburg	Germany	66421
13	Universitätsklinikum Schleswig-Holstein	Kiel	Germany	24105