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Clinical Trials/NCT02827448
NCT02827448
Completed
Not Applicable

Urinary Cell Cycle Arrest Biomarkers as Early Predictors of Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Baylor Research Institute1 site in 1 country300 target enrollmentNovember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Kidney Injury
Sponsor
Baylor Research Institute
Enrollment
300
Locations
1
Primary Endpoint
[TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study is to test how well the NephroCheckTM Test, a noninvasive laboratory test performed on urine, predicts loss of kidney function in patients that have had a heart transplant or a Left Ventricular Assist Device (LVAD) or Total Artificial Heart (TAH) implanted.

Detailed Description

Current strategies for AKI detection rely primarily on elevations in serum creatinine in conjunction with diminished urine output. Unfortunately, deviations in these crude parameters of renal function are largely insensitive and late manifestations of AKI, where acute tubular necrosis has likely already transpired and therefore well beyond the phase where preventive measures may be instituted. Early phase biomarkers, insulin-like growth factor-binding protein 7 ("IGFBP7") and tissue inhibitor of metalloproteinases-2 ("TIMP-2") are critical mediators of G1 cell cycle arrest of renal tubular cells during the early phase of cellular injury, providing a potential therapeutic window to prevent permanent damage. To date, no study has evaluated the efficacy of these early phase renal biomarkers for detecting AKI in advanced heart failure patients undergoing cardiac replacement therapies. Therefore, the aim of this prospective observational study will be to evaluate the effectiveness of the NephroCheckTM to predict AKI in patients undergoing transplant, LVAD implant, or TAH implant.

Registry
clinicaltrials.gov
Start Date
November 2015
End Date
June 2018
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who will receive LVAD or heart transplantation

Exclusion Criteria

  • Patients who are unable to give consent

Outcomes

Primary Outcomes

[TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation

Time Frame: 1 year

Occurrence of AKI following LVAD or TAH implantation

Time Frame: 1 year

Secondary Outcomes

  • [TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation(1 year)

Study Sites (1)

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