Search for Noninvasive Markers of "Graft Injury" in Pediatric and Adult Patients With Congenital Heart Disease Undergoing Cardiac Transplantation
Key facts
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 20 people, planned
- Started
- 8 Mar 2023
- Planned end
- 7 Mar 2026
- Type of study
- Interventional
- Treatments tested
- Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)
- Record updated
- 20 January 2025
Who can take part
- Age
- Up to 44 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- 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
Who cannot take part
- Failure to obtain informed consent from the adult patient or parent/guardian in case of minor
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyContact: Luca Ragni, MDTaking people
About the trial
What the trial wants to find out
This clinical tissue-based, drug-free, single-center, longitudinal study aims to validate a new diagnostic method, namely, to evaluate whether plasma levels of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA), in patients undergoing orthotopic heart transplantation, can be predictive of the presence of acute myocardial rejection with the same sensitivity as immunohistochemical analysis on endomyocardial biopsy specimen, the current gold standard for the diagnosis of acute cell-mediated myocardial rejection, in a population consisting of pediatric patients and adult patients with congenital heart disease undergoing orthotopic heart transplantation.
The group in the trial
- Endomyocardial biopsy and analysis for the presence of dd-cfDNAOther group
Whenever a patient enrolled in the study undergoes endomyocardial biopsy, either as part of surveillance of acute myocardial rejection or for clinical suspicion of rejection, concomitantly a blood sample will be taken and analyzed for the presence of dd-cfDNA. In patients with biopsy evidence of acute rejection, a new dd-cfDNA sampling will be performed approximately three months after treatment at the next clinical follow-up
Treatment: Evaluation of circulating donor free DNA in the recipient's blood (Dd-cfDNA: donor-derived cell free DNA)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 20 January 2025