Evaluating endomyocardial biopsy and tailored treatments for pediatric inflammatory heart disease
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
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 |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 0 Years to 17 Years |
| Sex | All |
| Sponsor | Scientific Institute San Raffaele Academic / other |
| Locations | 1 site (Milan, Milano) |
| Trial ID | NCT06591260 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients under 18 years of age with clinically suspected myocarditis.
Not a fit: Patients over 18 years of age or those who do not provide written informed consent will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, Milano
- IRCCS San Raffaele Scientific Institute — Milan, Milano, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Peretto, MD
- Email: peretto.giovanni@hsr.it
- Phone: +39 0226437482
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.