Actively Recruiting
Search for Noninvasive Markers of Graft Injury in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-01-20
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new diagnostic method to detect acute myocardial rejection in patients undergoing orthotopic heart transplantation. This study includes both pediatric and adult patients with congenital heart disease. The goal is to see if measuring plasma levels of donor-derived cell free DNA (Dd-cfDNA) in the recipient's blood can predict rejection as accurately as the current gold standard, which is immunohistochemical analysis of endomyocardial biopsy samples. In this drug-free study, about 20 patients will be enrolled and monitored at a single center. Whenever a patient has an endomyocardial biopsy for rejection surveillance or suspicion, a blood sample will be taken at the same time to analyze Dd-cfDNA levels. If acute rejection is confirmed by biopsy, the patient will have another Dd-cfDNA blood test approximately three months after treatment during their next follow-up visit. Blood samples will be processed using next-generation sequencing and specialized software to determine the percentage of donor DNA compared to recipient DNA. Participants will have routine clinical follow-up visits where their physical measurements, imaging, laboratory tests, biopsy results, and blood tests for donor DNA will be collected. The primary outcome is the measurement of circulating Dd-cfDNA levels in the blood, assessed on the day of biopsy. This study will provide important data on whether this less invasive blood test can effectively monitor heart transplant rejection. The study is expected to continue until March 2026.
CONDITIONS
Brief Title
Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with congenital heart disease undergoing cardiac transplantation at the study center or other centers but followed at the study center
- Pediatric patients undergoing cardiac transplantation at the study center or other centers but followed at the study center
- Obtaining informed consent from adult patients or parent/guardian for minors
You will not qualify if you...
- Failure to obtain informed consent from adult patients or parent/guardian for minors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Occurs as needed during the transplant follow-up period
Participants undergo endomyocardial biopsy as part of surveillance or clinical suspicion of rejection, with blood samples taken concurrently to analyze donor-derived cell free DNA (dd-cfDNA).
Visits occur whenever biopsy is performed; blood samples taken at the same time
Duration - Approximately 3 months after treatment and ongoing clinical follow-up
Participants with biopsy evidence of acute rejection have additional dd-cfDNA blood sampling approximately three months after treatment during clinical follow-up visits. Baseline and follow-up data including imaging, laboratory, and biopsy results are collected as part of routine care.
1 visit approximately 3 months after treatment plus routine clinical follow-up visits
Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Italy, 40138
Actively Recruiting
Research Team
L
Luca Ragni, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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