Non-invasive detection of heart transplant rejection in children
Official title: Non-invasive Detection of Acute Cell-mediated Graft Rejection in Pediatric Heart Transplant Recipients: the Role of Cardiovascular Magnetic Resonance
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT06795958 · Data updated 2026-11-12
This study is testing if a new type of heart imaging can safely detect rejection in children who have had a heart transplant, instead of using more invasive methods.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Status | Recruiting |
| Started | December 12, 2023 |
| Main results expected | June 30, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | January 28, 2025 |
| Trial ID | NCT06795958 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children and young adults who have undergone heart transplantation before the age of 18 and are scheduled for routine EMB surveillance.
✕Probably not a fit
Patients who are less than 3 months post-heart transplantation may not benefit from this study due to confounding factors from ischemia-reperfusion injury.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of multiparametric cardiac magnetic resonance (CMR) imaging as a non-invasive method for detecting acute graft rejection in pediatric heart transplant recipients. Currently, acute rejection is diagnosed through invasive endomyocardial biopsy (EMB), which carries risks and limitations. By utilizing CMR, the study seeks to characterize myocardial structure and function, and compare textural features of parametric maps between cases of rejection and those without. The goal is to improve the diagnosis of acute rejection and enhance patient care.
Why it matters
Potential benefit: If successful, this approach could provide a safer, non-invasive alternative for monitoring heart transplant rejection in pediatric patients.
How similar studies have gone: While few studies have explored the use of CMR in this context, the approach is relatively novel and has not been extensively tested in pediatric heart transplant recipients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * children and young adults (transplanted when they were ≤ 18 years) who undergo an EMB for routine surveillance without contraindications to contrast-enhanced CMR Exclusion Criteria: * We also don't recruit recipients who were \< 3 months post-heart transplantation to reduce the possibility of confounding from ischemia-reperfusion injury that occurs with the heart transplant procedure
Where it's running
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IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy Recruiting
Study contacts
- Principal investigator: Valentina Gesuete, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Valentina Gesuete, MD
- Email: valentina.gesuete@aosp.bo.it
- Phone: 0390512149096
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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.