Recruitment

Recruitment Status
Active, not recruiting

Summary

Conditions
Heart Transplantation
Type
Observational
Design
Observational Model: CohortTime Perspective: Retrospective

Participation Requirements

Age
Between 10 years and 70 years
Gender
Both males and females

Description

The proof of concept underlying uPROPHET rests on the EPLORE findings that capillary electrophoresis coupled with high-resolution mass-spectroscopy reproducibly identified unique urinary proteomic (UP) signatures associated with subclinical left ventricular dysfunction, renal impairment and adverse ...

The proof of concept underlying uPROPHET rests on the EPLORE findings that capillary electrophoresis coupled with high-resolution mass-spectroscopy reproducibly identified unique urinary proteomic (UP) signatures associated with subclinical left ventricular dysfunction, renal impairment and adverse cardiovascular outcomes. Consensus criteria currently applied for the selection of patients for heart transplantation (HTx) leave an inconvenient margin of uncertainty, because of the unpredictable course of the disease and the shortage of donor hearts. Furthermore, monitoring graft function and adjusting immunosuppression remain major challenges after HTx. Endomyocardial biopsies, up to 20 in the first year after HTx, are the standard approach to detect graft rejection, but require an invasive risk-carrying procedure. uPROPHET aims to develop UP profiling: (1) as a prognostic tool helpful in selecting terminally ill heart failure patients for HTx with the greatest probability of survival while adding a maximum of high-quality years to life; and (2) as an instrument to monitor graft performance and immune system activity and to manage immunosuppression. The new UP classifiers will be initially validated by demonstrating analogy between the proteomic profiles in urine and tissue samples of explanted hearts.

Tracking Information

NCT #
NCT03152422
Collaborators
Not Provided
Investigators
Principal Investigator: Jan A Staessen, MD, PhD University of Leuven