Identifying noninvasive markers of heart transplant rejection in patients with congenital heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.