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MyocarditisNCT07086144

Efficacy of a Myocardial Panel in the Management and Treatment of Pediatric Myocarditis

A study testing Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis in people with Myocarditis, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational study is to determine the efficacy a of combined management and treatment driven by the systematic determination of viral genome, bacterial serology, and markers of inflammation in pediatric patients (< 18 years old) diagnosed with myocarditis complicated by arrhythmias (supraventricular… Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Myocarditis
What is being tested?
Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
1 Jan 2024to 31 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All the consecutive pediatric patients (< 18 years old) presenting with myocarditis complicated by arrhythmias or myocardial dysfunction

Who cannot join

  • Refused consent to be included in the study given by parents or legal tutors
  • Uncomplicated myocarditis presenting without arrhythmias or myocardial dysfunction

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Francesco Bianco, M.D., Ph.D., MSc, FEACVI contact

+39 071 596 5527

francesco.bianco@ospedaliriuniti.marche.it

Italy1 site, 1 recruiting

  • Francesco Bianco

    Ancona, The Marches, 60126

    Francesco Bianco, M.D., Ph.D., MSc., FEACVI, + 39 071 596 5527, francesco.bianco@ospedaliriuniti.marche.it

    Federica Zallocco, M.D.

    Recruiting

Other trials in Italy

About this study

Official title: Efficacy of a Myocardial Panel (Virological, Bacterial and Autoimmune) in the Management and Treatment of Pediatric Myocarditis Complicated With Arrhythmias or Ventricular Dysfunction

The goal of this observational study is to determine the efficacy a of combined management and treatment driven by the systematic determination of viral genome, bacterial serology, and markers of inflammation in pediatric patients (< 18 years old) diagnosed with myocarditis complicated by arrhythmias (supraventricular and ventricular tachycardias and heart block) or ventricular dysfunction (left ventricular ejection fraction < 50% or right ventricular fractional area change < 35%).

The main question it aims to answer is: Does this panel help resolve arrhythmias or myocardial dysfunction due to myocarditis during hospitalisation and follow-up?

Researchers will compare patients managed and treated in 2024 without applying the myocarditis panel with those enrolled in 2025 who received the panel. Arrhythmias and myocardial dysfunction will be managed in accordance with recent guidelines. Antiviral, antibiotic or immunosuppressive therapies will be implemented in addition to standard therapy when required by the panel.

Read the detailed description

The Investigators will enrol consecutive pediatric patients (< 18 years old) presenting with myocarditis complicated by arrhythmias or ventricular dysfunction.

The participants will undergo routine daily visits and electrocardiographic and echocardiographic assessment during hospitalisation (within 8 weeks).

During follow-up, a routine visit including an echocardiogram, ECG, and blood tests (complete blood count, liver function tests, renal function tests, inflammation indices, and myocardial necrosis tests) will be performed within the first 40 days of discharge; thereafter, every 3 months after discharge for a total of 6 months of follow-up.

Conditions
Myocarditis
Being tested
Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis
Keywords
pediatric myocarditis, Arrhythmias, Myocarditis panel, Etiological therapy, Myocardial dysfunction
Medical subject headings
Myocarditis, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditisDiagnostic test

    N=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel

Study groups in NCT07086144
Study groupRoleWhat they receive
Myocarditis PanelExperimentalN=15 patients from 2025, in which management and treatment of arrhythmias and or myocardial dysfunction were driven by the panel
Receives: Diagnostic Test: Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis
No PanelNo interventionThe 15 patients managed and treated for arrhythmias or myocardial dysfunction in 2024 without applying the myocarditis panel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Arrhythmias duration

    Total duration of in-hospital arrhythmias assessed by electrocardiography

    Measured: From enrollment to the end of the hospitalisation (maximum of 8 weeks)

  2. Myocardial dysfunction

    Total duration of myocardial dysfunction assessed by echocardiography

    Measured: From enrollment to the end of the hospitalisation (maximum of 8 weeks)

Secondary outcomes (1)

  1. Follow-up

    Recurrences of arrhythmias or myocardial dysfunction at the follow-up

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jul 2025
  2. Study start1 Jan 2024
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
15 patients managed and treated in 2024 without applying the myocarditis panel with 15 patients from 2025, in which management and treatment were driven by the panel.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07086144
Sponsor's protocol ID
CCPC - SALESI 001/2025
Status last verified
Jul 2025
First submitted
18 Jul 2025
Last updated
25 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD will be shared upon reasonable requests from other investigators.

Publications

  • Pompa AG, Beerman LB, Feingold B, Arora G. Electrocardiogram changes in pediatric patients with myocarditis. Am J Emerg Med. 2022 Sep;59:49-53. doi: 10.1016/j.ajem.2022.06.027. Epub 2022 Jun 17.

    PubMed 35779288

  • Law YM, Lal AK, Chen S, Cihakova D, Cooper LT Jr, Deshpande S, Godown J, Grosse-Wortmann L, Robinson JD, Towbin JA; American Heart Association Pediatric Heart Failure and Transplantation Committee of the Council on Lifelong Congenital Heart Disease and Heart Health in the Young and Stroke Council. Diagnosis and Management of Myocarditis in Children: A Scientific Statement From the American Heart Association. Circulation. 2021 Aug 10;144(6):e123-e135. doi: 10.1161/CIR.0000000000001001. Epub 2021 Jul 7.

    PubMed 34229446

  • Dasgupta S, Iannucci G, Mao C, Clabby M, Oster ME. Myocarditis in the pediatric population: A review. Congenit Heart Dis. 2019 Sep;14(5):868-877. doi: 10.1111/chd.12835. Epub 2019 Aug 21.

    PubMed 31432626

  • Ammirati E, Veronese G, Bottiroli M, Wang DW, Cipriani M, Garascia A, Pedrotti P, Adler ED, Frigerio M. Update on acute myocarditis. Trends Cardiovasc Med. 2021 Aug;31(6):370-379. doi: 10.1016/j.tcm.2020.05.008. Epub 2020 Jun 1.

    PubMed 32497572

  • Ammirati E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023 Apr 4;329(13):1098-1113. doi: 10.1001/jama.2023.3371.

    PubMed 37014337

  • Ammirati E, Frigerio M, Adler ED, Basso C, Birnie DH, Brambatti M, Friedrich MG, Klingel K, Lehtonen J, Moslehi JJ, Pedrotti P, Rimoldi OE, Schultheiss HP, Tschope C, Cooper LT Jr, Camici PG. Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document. Circ Heart Fail. 2020 Nov;13(11):e007405. doi: 10.1161/CIRCHEARTFAILURE.120.007405. Epub 2020 Nov 12.

    PubMed 33176455

Questions about this trial

What is this clinical trial studying?

A study testing Determination of viral genome, bacterial serology, and markers of inflammation in pediatrics diagnosed with myocarditis in people with Myocarditis, run by Azienda Ospedaliero, Universitaria Ospedali Riuniti at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Francesco Bianco, M.D., Ph.D., MSc, FEACVI (+39 071 596 5527, francesco.bianco@ospedaliriuniti.marche.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arrhythmias duration (time frame: From enrollment to the end of the hospitalisation (maximum of 8 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07086144, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2025.

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