Clinical trial NCT03152422: Urinary Proteomics in Predicting Heart Transplantation Outcomes
Official title: Urinary Proteomics in Predicting Heart Transplantation Outcomes
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Transplantation
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 352
Sex: ALL
Minimum age (years): 10
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End-stage heart failure due to ischemic, dilated or hypertrophic cardiomyopathy

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Cardiovascular events
timeFrame: 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.
Secondary outcomes:
measure: Graft performance
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: University of Leuven
name: Jan A Staessen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.