Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)

Sponsor
University Hospital, Rouen
Study ID
NCT04930549
Phase
PHASE2
Status
Completed

Conditions

  • Renal Insufficiency, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10Mg Tab — DRUG
    Patients receive dapagliflozin 10mg tablets once a day during 12 weeks
  • Placebo — DRUG
    Patients receive placebo tablets once a day during 12 weeks
  • impedance cardiography — PROCEDURE
    impedance cardiography (PhysioFlow® PF-05 Lab1TM, Manatec Biomedical) is done for evaluation of cardiac function
  • Applanation tonometry — PROCEDURE
    Applanation tonometry will be done using SphygmoCor®, Hogimed) is done for evaluation of arterial stiffness
  • post-ischemic hyperemia of forearm — PROCEDURE
    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®)
  • haemodynamics parameters — PROCEDURE
    haemodynamics parameters will be evaluated using automatic oscillometric recorder

Study Details

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.

Key Dates

Start date
Oct 18, 2022
Status verified
Nov 2022
Primary completion
Sep 23, 2024
Completion
Sep 23, 2024

Study Design

Enrollment
32 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10Mg Tab
    Dapagliflozin 10 mg film-coated tablets
  • Placebo Comparator: Placebo
    Identical film-coated tablets without dapagliflozin

Primary Outcome Measure

Change from baseline of brachial artery endothelial function using echography [ Time Frame: 12 weeks ]

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