Myocarditis Registry for Children and Adolescents - MYKKE

Myocarditis Clinical Trial

— MYKKE  

Official title:

Myocarditis Registry for Children and Adolescents - MYKKE

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02590341
• Other study ID #: MYKKE Registry
• Status: Recruiting
• Phase: N/A
• First received: October 8, 2015
• Last updated: October 27, 2015
• Start date: June 2014
• Est. completion date: May 2024

Study information

• Verified date: October 2015
• Source: German Heart Institute
• Contact: Thomas Pickardt, PhD
• Phone: +49 30 4593
• Email: pickardt[@]kompetenznetz-ahf.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical 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 disease.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myocarditis

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum NRW	Bad Oeynhausen
Germany	Charite - Universitätsmedizin Berlin	Berlin
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Klinikum Links der Weser	Bremen
Germany	Universitätsklinikum Erlangen	Erlangen
Germany	Universitäts-Herzzentrum Freiburg - Bad Krozingen	Freiburg
Germany	Universitätsklinikum Giessen und Marburg	Giessen
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitäres Herzzentrum Hamburg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Universitätsklinikum des Saarlandes	Homburg
Germany	Universitätsklinikum Schleswig-Holstein	Kiel

Sponsors (2)

Lead Sponsor	Collaborator
German Heart Institute	Competence Network for Congenital Heart Defects

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	medium-term all cause mortality	mortality due to all causes at 5 years	five years	No
Other	long-term all cause mortality	mortality due to all causes at 10 years	ten years	No
Other	medium-term admission for heart failure	admission for heart failure at 5 years	five years	No
Other	long-term admission for heart failure	admission for heart failure at 10 years	ten years	No
Other	medium-term major cardiovascular events	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)	five years	No
Other	long-term major cardiovascular events	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)	ten years	No
Other	medium-term systolic dysfunction	left ventricular ejection fraction <50%	five years	No
Other	long-term systolic dysfunction	left ventricular ejection fraction <50%	ten years	No
Other	medium-term diastolic dysfunction	elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%	five years	No
Other	long-term diastolic dysfunction	elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >=50%	ten years	No
Other	medium-term impaired exercise tolerance	maximal oxygen uptake (VO2max) <5th percentile of normal	five years	No
Other	long-term impaired exercise tolerance	maximal oxygen uptake (VO2max) <5th percentile of normal	ten years	No
Primary	all cause mortality		one year	No
Primary	admission for heart failure		one year	No
Primary	major cardiovascular events	cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy	one year	No
Secondary	systolic dysfunction	left ventricular ejection fraction <50%	one year	No
Secondary	diastolic dysfunction	elevated natriuretic peptides, E/E' >15, left ventricular ejection fraction >= 50%	one year	No
Secondary	impaired exercise tolerance	maximal oxygen uptake (VO2max) <5th percentile of normal	one year	No

External Links

•   MYKKE project on the website of Competence Network for Congenital Heart Defects
•   Website of MYKKE registry (German language only)