Urinary Proteomics in Predicting Heart Transplantation Outcomes

Heart Transplantation Clinical Trial

— uPROPHET  

Official title:

Urinary Proteomics in Predicting Heart Transplantation Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03152422
• Other study ID #: ERC PoC 713601-uPROPHET
• Status: Active, not recruiting
• Start date: October 1, 2016
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2020
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 352
• Est. completion date: December 31, 2025
• Est. primary completion date: May 8, 2017
• Gender: All
• Age group: 10 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heart Transplantation

Intervention

Diagnostic Test:
• Urinary proteomics
Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
KU Leuven

References & Publications (4)

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, Droogné W, Vanhaecke J, Janssens S, Van Cleemput J, Mischak H, Staessen JA. Biomarkers to Assess Right Heart Pressures in Recipients — View 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, Droogné W, Vlahou A, Janssens S, Vanhaecke J, Van Cleemput J, Staessen JA. Urinary Proteomics in Predicting Heart Transplantation Outco — View 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 ß-blockade and heart rate in hea — View 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. Nep — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	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.

External Links

•   Description of study at the website of the University of Leuven