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Superiority Assessment of Donor-derived Cell-FreE DNA ( Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring
Sponsor: Assistance Publique - Hôpitaux de Paris
Summary
Heart transplantation (HTx) remains the gold-standard treatment for patients with end-stage heart failure refractory to the medical management, offering the best survival and quality of life. In the absence of a reliable non-invasive biomarker, international guidelines recommend to screen for cardiac allograft rejection during the first-year post-transplant using iterative protocol endomyocardial biopsies, a stressful and invasive procedure at risk of periprocedural complications. This invasive strategy suffers from multiple limitations and is increasingly being questioned. Recently, circulating donor-derived cell-free DNA (dd-cfDNA) ""Donor-derived cell-FreE Deoxyribonucleic Acid"", has been proposed as a reliable non-invasive biomarker of rejection in solid organ transplantation. Strong associations between allograft rejection and dd-cfDNA have been found in observational studies. Although donor-derived cell-free DNA (dd-cfDNA) is considered as the most promising non-invasive biomarker of allograft injury by international experts, no interventional trial has ever confirmed the efficiency and the safety of the non-invasive monitoring of rejection using dd-cfDNA. This prospective validation is mandatory and represents an important unmet medical need.We hypothesize that a non-invasive dd-cfDNA-based strategy might be superior to an invasive biopsy-based strategy for the screening of rejection in terms of patients' survival, allograft function and quality of life.
Official title: Superiority Assessment of Donor-derived Cell-FreE DNA(Deoxyribonucleic Acid) for Cardiac Allograft REjection Monitoring - A Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2026-12-01
Completion Date
2030-11-01
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
non-invasive strategy based of the analysis of circulating dd-cfDNA (AlloSeq cfDNA assay)
"202 single nucleotide polymorphisms and advanced bioinformatics tools to quantify dd-cfDNA. The quantification of dd-cfDNA will be performed at each follow-up visit (n = 8). In the experimental group, no protocol EMB will be performed outside of the end-of-study visit (protocol biopsy at Month 11 in both groups). EMB will only be allowed if clinically indicated or in case of abnormal value of dd-cfDNA. "
control
Standard of care monitoring of cardiac allograft rejection based on iterative protocol endomyocardial biopsies during the first-year post-transplant (8 follow-up visits)