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Validation of the clinical utility of microRNA as noninvasive biomarkers of cardiac allograft rejection: A prospective longitudinal multicenter study. | LitMetric

Validation of the clinical utility of microRNA as noninvasive biomarkers of cardiac allograft rejection: A prospective longitudinal multicenter study.

J Heart Lung Transplant

University of Paris, INSERM UMR 970, Paris Translational Research Centre for Organ Transplantation, Paris, France; Kidney Transplant Department, Necker Hospital, Assistance Publique-Hôpitaux de Paris, Paris, France.

Published: November 2023

AI Article Synopsis

  • A prospective study was conducted to examine the association between three specific circulating microRNAs (10a, 92a, 155) and cardiac rejection in heart transplant recipients across 11 centers from August 2016 to March 2018.
  • The study involved 461 patients and 831 biopsies, of which 79 indicated rejection; however, the interim analysis found no significant association between the microRNAs and rejection diagnosis.
  • Ultimately, the research concluded that monitoring these microRNAs does not provide clinical utility for heart transplant recipients, leading to the decision to halt further analysis for futility.

Article Abstract

While studies have shown an association between microRNAs and cardiac rejection, the clinical relevance of a preidentified miRNA signature as a noninvasive biomarker has never been assessed in prospective multicentric unselected cohorts. To address this unmet need, we designed a prospective study (NCT02672683) including recipients from 11 centers between August 2016 to March 2018. The objective was to validate the association between 3 previously identified circulating microRNA (10a, 92a, 155) and the histopathological diagnosis of rejection. Both relative and absolute (sensitivity analysis) quantifications of microRNAs were performed. Overall, 461 patients were included (831 biopsies, 79 rejections). A per-protocol interim analysis (258 biopsies, 49 rejections) did not find any association between microRNA and rejection (microRNA 10a: odds ratio (OR) = 1.05, 95% confidence intervals (CI) = 0.87-1.27, p = 0.61; 92a: OR = 0.98, 95%CI = 0.87-1.10, p = 0.68; 155: OR = 0.91, 95%CI = 0.76-1.10, p = 0.33). These results were confirmed in the sensitivity analysis. The analysis of the remaining sera was stopped for futility. This study shows no clinical utility of circulating microRNAs 10a, 92a, and 155 monitoring in heart allograft recipients.

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Source
http://dx.doi.org/10.1016/j.healun.2023.07.010DOI Listing

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