NCT04930549

Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)

Impact of Dapagliflozin on Vascular Function in Chronic Kidney Disease Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Rouen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Renal Insufficiency, Chronic

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10Mg Tab	Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
DRUG	Placebo	Patients receive placebo tablets once a day during 12 weeks
PROCEDURE	impedance cardiography	impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
PROCEDURE	Applanation tonometry	Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
PROCEDURE	post-ischemic hyperemia of forearm	An arterial occlusion cuff will be placed on the forearm, and will be deflated to allow post-ischemic hyperemia with the continuous measurements of brachial artery diameter and blood flow velocity by high-resolution echotracking coupled to a Doppler system (ArtLab system®)
PROCEDURE	haemodynamics parameters	haemodynamics parameters will be evaluated using automatic oscillometric recorder

Timeline

• Start date: 2022-10-18
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2021-06-18
• Last updated: 2026-02-06

Locations

2 sites across 1 country: France