Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC) — DAPAVASC  

Renal Insufficiency, Chronic Clinical Trial

Official title: Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients

Status Not yet recruiting

Clinical Trial Summary

This study aims to determine whether dapaglfiflozin 12-week administration is associated with a beneficial impact on the vasculature of patients with chronic kidney disease.

Clinical Trial Description

A prospective, randomized, double-blind studies evaluating the impact of once-daily dapagliflozin 10 mg versus placebo for 12 weeks on endothelial function, as primary endpoint, will be conducted in 56 patients with chronic kidney disease (eGFR ≥25 and ≤60 mL/min/1.73m2 by CKD-EPI) and without diabetes (fasting glycemia≥1.26 mg/dL, oral hypoglycemic agents or insulin) on top of standard treatment (n=27 per group). Indexes of arterial stiffness, cardiovascular coupling, cardiac function and plasma concentrations of endothelial, inflammatory and oxidative stress biomarkers will be assessed as secondary endpoints. Patients will be recruited in the Departments of Cardiology and Nephrology of Rouen University Hospital. The study will include an inclusion visit (V1), 2 exploration visits performed before (V2) and 12 weeks (V3) after treatment initiation, and 1 output study (V4). ;

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

• NCT number: NCT04930549
• Study type: Interventional
• Source: University Hospital, Rouen
• Contact: Julien Blot
• Phone: +33232884035
• Email: julien.blot@chu-rouen.fr
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2021
• Completion date: March 31, 2023