CompletedNot Applicable

Evaluation of the Added Clinical Value of Donor-derived Cell-free DNA for the Monitoring of Cardiac Allograft Rejection.

France320 participantsStarted 2021-10-01

Plain-language summary

The goal of this observational study is to assess the clinical added value of donor-derived cell-free DNA (dd-cfDNA) to monitor cardiac allograft rejection. The main question it aims to answer is whether dd-cfDNA is independently associated with rejection and if it allows a significant improvement in individual risk stratification of rejection on top of a robust predictive model based on standard clinical and biological predictive variables.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * heart transplant recipients, * heart transplantation performed for more than 30 days, * clinical indication of an endomyocardial biopsy, either protocol or for cause, * informed consent Exclusion Criteria: * multiorgan transplantation * refusal to participate

What they're measuring

Number of patients with biopsy proven rejection and / or acute allograft dysfunction

Timeframe: 12 months

Trial details

NCT IDNCT06740578

SponsorParis Translational Research Center for Organ Transplantation

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-31

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