Evaluating endomyocardial biopsy and tailored treatments for pediatric inflammatory heart disease
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
Run by Scientific Institute San Raffaele · NCT06591260 · Data updated 2026-11-12
This study is testing how a heart tissue sample and personalized treatments can help kids with inflammatory heart disease, especially those with myocarditis and heart rhythm issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 17 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Status | Recruiting |
| Started | January 1, 2013 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2030 |
| Registry record updated | September 19, 2024 |
| Trial ID | NCT06591260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients under 18 years of age with clinically suspected myocarditis.
✕Probably not a fit
Patients over 18 years of age or those who do not provide written informed consent will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the role of endomyocardial biopsy (EMB) and aetiology-based treatments in pediatric patients with inflammatory heart disease, particularly focusing on myocarditis and its arrhythmic manifestations. It includes both retrospective and prospective phases, collecting clinical data before and after the diagnosis of myocarditis. The study aims to compare EMB with noninvasive diagnostic techniques and assess blood biomarkers for various clinical outcomes. Additionally, it seeks to describe the presentation of myocarditis with arrhythmias and evaluate healing times across different patient subgroups.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and therapeutic strategies for pediatric patients with inflammatory heart disease, potentially enhancing patient outcomes.
How similar studies have gone: While the approach of using EMB in myocarditis is established, the specific integrated methodology of this study is novel and aims to address gaps in current diagnostic and treatment strategies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent. * Age \< 18 years. * Clinically suspected myocarditis. * Enrollment performed by one of the participating Centers. Exclusion Criteria: * Absence of written informed consent. * Age \> 18 years (adults)
Where it's running
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IRCCS San Raffaele Scientific Institute
Milan, Milano, Italy Recruiting
Study contacts
- Study coordinator: Giovanni Peretto, MD
- Email: peretto.giovanni@hsr.it
- Phone: +39 0226437482
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.