Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058857) titled 'Development of a Predictive Model for Acute Kidney Injury (AKI) and Acute Kidney Disease (AKD) in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)' on Aug. 21.

Study Type: Observational

Primary Sponsor: Institute - St. Marianna university school of medicine

Condition: Condition - Aortic valve stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - We aim to identify clinical and biochemical predictors of acute kidney injury (AKI) and acute kidney disease (AKD) in patients undergoing transcatheter aortic valve implantation (TAVI), and to develop and validate a predictive model incorporating urinary biomarkers. The biomarkers to be analyzed include urinary L-FABP, NGAL, KIM-1, TIMP-2-IGFBP7, and clusterin, whose measurements were previously collected and analyzed in study No. 3049. These data will be further reanalyzed using nomograms, calibration plots, decision curve analysis (DCA), and bootstrap methods. We will observe the extent and dynamics of perioperative biomarker elevation, and investigate their association with AKD onset, chronic kidney disease (CKD) development and severity, and the rate of decline in estimated glomerular filtration rate (eGFR). Finally, we will evaluate whether AKI and AKD onset and renal prognosis, as well as survival prediction, can be accurately assessed using this model. Basic objectives2 - Others

Eligibility: Age-lower limit - 50 years-old

Gender - Male and Female Key inclusion criteria - Patients scheduled to undergo transcatheter valve implantation who provided informed consent prior to the procedure Key exclusion criteria - Excluded dialysis patients and emergency cases Target Size - 500

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 07 Day Date of IRB - 2025 Year 09 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067311

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