Heart Transplantation
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTUrinary proteomics
Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant
Sponsors
KU Leuven
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Inclusion criteria
* End-stage heart failure resistant to treatment
Exclusion criteria
* According to guidelines (J Heart Lung Transplant 2010;29:717-27 and J Heart Lung Transplant 2016; 35: http://dx.doi.org/10.1016/j.healun.2015.10.023).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular events | Patients were followed up from the date of first urine sampling until death or censoring on the date of the last available follow-up visit (median 4 years). Events will be reported at study completion. | This endpoint is available in the hospital records |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Graft performance | Patients were followed up from the date of first urine sampling until death or censoring on the date of the last available follow-up visit (median 4 years). Events will be reported at study completion. | Monitoring using endomyocardial biopsies and hemodynamic measurements |
Outcome results
None listed