Urinary Proteomics in Predicting Heart Transplantation Outcomes

NCT03152422 | Unknown

• 1 other identifier: ERC PoC 713601-uPROPHET
• Study Type: observational
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Heart Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

Urinary proteomics DIAGNOSTIC_TEST

Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant

Eligibility Criteria

• Age: 10 Years - 70 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

End-stage heart failure due to ischemic, dilated or hypertrophic cardiomyopathy

You may qualify if:

• End-stage heart failure resistant to treatment

You may not qualify if:

• 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).

Sponsors & Collaborators

• KU Leuven: lead

Related Publications (4)

• 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.

  PMID: 28880921 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.

  PMID: 29796417 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.

  PMID: 29982668 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.

  PMID: 30248148 RESULT

Related Links

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

Study Officials

• Jan A Staessen, MD, PhD

  University of Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 15, 2017
• Study Start: October 1, 2016
• Primary Completion: May 8, 2017
• Study Completion: December 31, 2025
• Last Updated: March 4, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Currently available until 2025
• Access Criteria: Appproval by the Ethics Committee of the University Hospitals Leuven