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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
Italy1 site in 1 countryChoose a country to see its sites
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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
20 January 2025