Effectiveness of NephroCheckTM Test to Predict Acute Kidney Injury Following Advanced Cardiac Replacement Therapies

Completed

• Conditions: Heart Failure; Acute Kidney Injury

• Registration Number: NCT02827448
• Lead Sponsor: Baylor Research Institute

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-24
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-11
• Primary Completion: 2017-08
• Study Completion: 2018-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients who will receive LVAD or heart transplantation

Exclusion Criteria

• Patients who are unable to give consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of AKI following LVAD or TAH implantation	1 year
[TIMP-2]*[IGFBP7] measurement using NephroCheck following LVAD or TAH implantation	1 year

Secondary Outcome Measures

Name	Time	Method
[TIMP-2]*[IGFBP7] measurement using NephroCheck following cardiac transplantation	1 year

Trial Locations

Locations (1)

Baylor Research Institute; 🇺🇸 Dallas, Texas, United States