Identifying noninvasive markers of heart transplant rejection in patients with congenital heart disease
Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
This study is testing a new blood test to see if it can help detect heart transplant rejection in patients with congenital heart disease without needing a more invasive procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 44 Years |
| Sex | All |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna) |
| Trial ID | NCT06784440 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to validate a new diagnostic method for detecting acute myocardial rejection in patients with congenital heart disease undergoing heart transplantation. The study will evaluate plasma levels of donor-derived cell-free DNA (Dd-cfDNA) in the recipient's blood and compare its effectiveness to the current gold standard, which is endomyocardial biopsy. Approximately 20 pediatric and adult patients will be enrolled, and blood samples will be collected during routine biopsies to analyze Dd-cfDNA levels. The goal is to determine if this noninvasive method can predict rejection with similar sensitivity as traditional biopsy methods.
Who should consider this trial
Good fit: Ideal candidates include pediatric and adult patients with congenital heart disease who are undergoing cardiac transplantation.
Not a fit: Patients who are not undergoing cardiac transplantation or those who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more accessible method for monitoring heart transplant rejection in patients with congenital heart disease.
How similar studies have performed: While the approach of using Dd-cfDNA is gaining interest, this specific application in congenital heart disease patients undergoing transplantation is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with congenital heart disease undergoing cardiac transplantation at our center or other centers, followed in follow-up at our center (Unit of Pediatric Cardiology and Developmental Age, IRCCS Azienda Ospedaliero-Universitaria di Bologna) * Pediatric patients undergoing cardiac transplantation at our center or other centers but followed in follow-up at our center * Obtaining informed consent from the adult patient or parent/guardian in case of minor Exclusion Criteria: * Failure to obtain informed consent from the adult patient or parent/guardian in case of minor
Where this trial is running
Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Ragni, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Luca Ragni, MD
- Email: luca.ragni@aosp.bo.it
- Phone: 0512149024
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.