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Studying diagnosis and treatment of myocarditis, including rhythm problems, in children

Observes how myocarditis is diagnosed and treated in children, including those with arrhythmias.

Key facts

Who runs it
Scientific Institute San Raffaele
Where
Italy1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management (MYOPED)
Status
Recruiting
People taking part
20 people, planned
Started
1 Jan 2013
Expected to end
31 Dec 2030
Type of study
Observational, 3 groups
Treatments tested
  • support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
Record updated
19 September 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers under 18 years with suspected myocarditis (inflammation of the heart muscle), with or without heart rhythm problems.

Age
Under 18 years (0 to 17 years).
Sex
All sexes can join.
Disease stage
Myocarditis suspected by the doctors, at any stage or presentation.

Main reasons for not taking part

  • No written informed consent.
  • Age over 18 years (adults).
  • Enrollment not done by one of the taking-part centers.

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • Written informed consent
  • Age \< 18 years
  • Clinically suspected myocarditis
  • Enrollment performed by one of the participating Centers

Who cannot take part

  • Age \> 18 years (adults)
  • Absence of written informed consent

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 0 and 17 years old?

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.

Read full original descriptionShow less

Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.

Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.

Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.

The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.

Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

The 3 groups in the trial

  • Arrhythmic (A)

    Arrhythmic Group. To oversimplify, specific subgroups of patients will be considered. Group 1: major ventricular arrhythmias (haemodynamically unstable VT, hu-VT; ventricular fibrillation, VF). Group 2: other ventricular arrhythmias (high-burden premature ventricular complexes = hb-PVC; nonsustained VT = NSVT; haemodynamically stable VT = hs-VT). Group 3: bradyarrhythmias (2nd type II or 3rd degree atrioventricular block = advanced AVB; critical sinus pauses = SND). Group 4: supraventricular arrhythmias (atrial fibrillation = AF; atrial flutter = AFlu; atrial tachycardia = AT).

    Treatment: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Nonarrhythmic (NA)

    Nonarrhythmic Group. To oversimplify, specific subgroups of patients will be considered. 1. Heart failure presentation (and subtypes) 2. Chest pain presentation (and subtypes) 3. Asymptomatic presentation/screening (and subtypes)

    Treatment: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

  • Subgroups

    For specific study aims, different patient subgroups will be compared. The main groups are hereby reported: A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…). C. Infectious vs. autoimmune vs. toxic myocarditis. D. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment. E. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis. F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease. G. Myocarditis vs. peri-myocarditis/myo-pericarditis. H. Other subgroups

    Treatment: support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Role of Endomyocardial Biopsy and Aetiology-based Treatment in Pediatric Patients with Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
Plain-language title
Studying diagnosis and treatment of myocarditis, including rhythm problems, in childrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT06591260, who can take part
Record updated
19 September 2024