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uPROPHET aims to validate urinary proteomics for risk stratification and monitoring graft performance is recipients of heart transplants
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Urinary proteomics | Diagnostic Test | Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular events | This endpoint is available in the hospital records | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Graft performance | Monitoring using endomyocardial biopsies and hemodynamic measurements | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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End-stage heart failure due to ischemic, dilated or hypertrophic cardiomyopathy
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| Name | Affiliation | Role |
|---|---|---|
| Jan A Staessen, MD, PhD | University of Leuven | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28880921 | Result | Huang QF, Trenson S, Zhang ZY, Yang WY, Van Aelst L, Nkuipou-Kenfack E, Wei FF, Mujaj B, Thijs L, Ciarka A, Zoidakis J, Droogne W, Vlahou A, Janssens S, Vanhaecke J, Van Cleemput J, Staessen JA. Urinary Proteomics in Predicting Heart Transplantation Outcomes (uPROPHET)-Rationale and database description. PLoS One. 2017 Sep 7;12(9):e0184443. doi: 10.1371/journal.pone.0184443. eCollection 2017. | |
| 29796417 |
| Label | URL |
|---|---|
| Description of study at the website of the University of Leuven | View source |
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Anonymized data can be made available for scientific purposes via a motivated request to Prof Jan A. Staessen. The request should receive approval by the Ethics Committee of the University Hospitals Leuven.
Currently available until 2025
Appproval by the Ethics Committee of the University Hospitals Leuven
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| Result |
| Huang QF, Trenson S, Zhang ZY, Van Keer J, Van Aelst LNL, Yang WY, Nkuipou-Kenfack E, Thijs L, Wei FF, Mujaj B, Ciarka A, Droogne W, Vanhaecke J, Janssens S, Van Cleemput J, Mischak H, Staessen JA. Biomarkers to Assess Right Heart Pressures in Recipients of a Heart Transplant: A Proof-of-Concept Study. Transplant Direct. 2018 Apr 23;4(5):e346. doi: 10.1097/TXD.0000000000000783. eCollection 2018 May. |
| 29982668 | Result | Huang QF, Zhang ZY, Van Keer J, Trenson S, Nkuipou-Kenfack E, Yang WY, Thijs L, Vanhaecke J, Van Aelst LNL, Van Cleemput J, Janssens S, Verhamme P, Mischak H, Staessen JA. Urinary peptidomic biomarkers of renal function in heart transplant recipients. Nephrol Dial Transplant. 2019 Aug 1;34(8):1336-1343. doi: 10.1093/ndt/gfy185. |
| 30248148 | Result | Huang QF, Van Keer J, Zhang ZY, Trenson S, Nkuipou-Kenfack E, Van Aelst LNL, Yang WY, Thijs L, Wei FF, Ciarka A, Vanhaecke J, Janssens S, Van Cleemput J, Mischak H, Staessen JA. Urinary proteomic signatures associated with beta-blockade and heart rate in heart transplant recipients. PLoS One. 2018 Sep 24;13(9):e0204439. doi: 10.1371/journal.pone.0204439. eCollection 2018. |