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