NCT02590341

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2014

Longer than P75 for all trials

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 8, 2015

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 29, 2015

Status Verified

October 1, 2015

Enrollment Period

9.9 years

First QC Date

October 8, 2015

Last Update Submit

October 27, 2015

Conditions

Myocarditis

Keywords

myocarditischildrenadolescentsregistrymulti-centerpediatricheart failureinflammatory heart diseaseinflammatory cardiomyopathy

Outcome Measures

Primary Outcomes (3)

  • all cause mortality

    one year

  • admission for heart failure

    one year

  • major cardiovascular events

    cardiovascular death, need for mechanical ventricular support or heart transplantation, sustained ventricular arrhythmia, decompensated heart failure requiring catecholamine therapy

    one year

Secondary Outcomes (3)

  • systolic dysfunction

    one year

  • diastolic dysfunction

    one year

  • impaired exercise tolerance

    one year

Other Outcomes (12)

  • medium-term all cause mortality

    five years

  • long-term all cause mortality

    ten years

  • medium-term admission for heart failure

    five years

  • +9 more other outcomes

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Patients admitted to pediatric heart centers or pediatric cardiology departments

You may qualify if:

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

You may not qualify if:

  • Unwillingness to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, 32545, Germany

RECRUITING

Charite - Universitätsmedizin Berlin

Berlin, 13353, Germany

RECRUITING

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

RECRUITING

Klinikum Links der Weser

Bremen, 28277, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Universitäts-Herzzentrum Freiburg - Bad Krozingen

Freiburg im Breisgau, 79106, Germany

RECRUITING

Universitätsklinikum Giessen und Marburg

Giessen, 35392, Germany

RECRUITING

Universitätsmedizin Göttingen

Göttingen, 37099, Germany

NOT YET RECRUITING

Universitäres Herzzentrum Hamburg

Hamburg, 20246, Germany

RECRUITING

Medizinische Hochschule Hannover

Hanover, 30625, Germany

RECRUITING

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

NOT YET RECRUITING

Universitätsklinikum des Saarlandes

Homburg, 66421, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, 24105, Germany

RECRUITING

Related Publications (1)

  • Seidel F, Nygren TM, Opgen-Rhein B, Hecht T, Boehne M, Weickmann J, Anderheiden F, Reineker K, Bocker D, Rentzsch A, Wiegand G, Fischer M, Kiski D, Frede W, Ruf B, Tarusinov G, Papakostas K, Logeswaran T, Schiebel A, Voges I, Kaestner M, Kramp J, Kerst G, Khedim M, Gatzweiler E, Wannenmacher B, Knirsch W, Meyer-Dobkowitz L, Donner B, Klingner J, Rau C, Haller S, Brinkmann A, Nitsche A, Noldt M, Schmoock G, Herzmann C, Degenhardt U, Buhler S, Enders M, Hermes J, Rolfs N, Manuylova T, Schwarzkopf E, Beudt J, Siffczyk C, Schubert S, Sandfort M, Klingel K. Severe Myocarditis Increase in Children Associated With Parvovirus B19 Infection: MYKKE Registry and German Surveillance Data. JACC Heart Fail. 2025 Dec 29:102854. doi: 10.1016/j.jchf.2025.102854. Online ahead of print.

    PMID: 41493405DERIVED

Related Links

MeSH Terms

Conditions

MyocarditisHeart Failure

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular Diseases

Study Officials

  • Daniel R Messroghli, MD

    German Heart Institute

    STUDY DIRECTOR

  • Stephan N Schubert, MD

    German Heart Institute

    STUDY DIRECTOR

Central Study Contacts

Thomas Pickardt, PhD

CONTACT

+49 30 4593pickardt@kompetenznetz-ahf.de

Manuela Bauer

CONTACT

+49 30 4593mabauer@dhzb.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 29, 2015

Study Start

June 1, 2014

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

October 29, 2015

Record last verified: 2015-10

Locations

DE(13)