NCT03152422

Urinary Proteomics in Predicting Heart Transplantation Outcomes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 352 (actual)
• Sponsor: KU Leuven · Academic / Other
• Sex: All
• Age: 10 Years – 70 Years
• Healthy volunteers: —

Summary

uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft performance is recipients of heart transplants

Detailed 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 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.

Conditions

• Heart Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urinary proteomics	Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-08
• Completion: 2025-12-31
• First posted: 2017-05-15
• Last updated: 2020-03-04