| Trial ID: | L0552 |
| Source ID: | NCT04930549
|
| Associated Drug: |
Dapagliflozin 10mg Tab
|
| Title: |
Vascular Impact of Dapagliflozin in CKD Patients (DAPAVASC)
|
| Acronym: |
DAPAVASC
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Dapagliflozin 10Mg Tab|DRUG: Placebo|PROCEDURE: impedance cardiography|PROCEDURE: Applanation tonometry|PROCEDURE: post-ischemic hyperemia of forearm|PROCEDURE: haemodynamics parameters
|
| Outcome Measures: |
Primary: Change from baseline of brachial artery endothelial function using echography, Change in brachial artery flow-mediated dilatation in response to post-ischemia hyperemia using difference of brachial artery diameter, 12 weeks | Secondary: Change from baseline of arterial stiffness using applanation tonometry, Change in carotid-to-femoral pulse wave velocity, 12 weeks|Change from baseline of carotid artery geometry using echography (1), Change in carotid diastolic diameter, 12 weeks|Change from baseline of carotid artery geometry using echography (2), Change in carotid intima-media thickness using echography, 12 weeks|Change from baseline of cardiac function by impedance cardiography (1), Change in cardiac output, 12 weeks|Change from baseline of cardiac function by impedance cardiography (2), Change in stroke volume, 12 weeks|Change from baseline of cardiac function by impedance cardiography (3), Change in ejection fraction, 12 weeks|Change from baseline of cardiac function by impedance cardiography (4), Change in end-diastolic volume, 12 weeks|Change from baseline of cardiac function by impedance cardiography (5), Change in total peripheral resistance,, 12 weeks|Change from baseline of cardiac function by impedance cardiography (6), Change in left ventricular end-systolic elastance, 12 weeks|Change from baseline of epoxyeicosatrienoic acid bioavailability, Change in epoxyeicosatroenoic acid bioavailibility during heating, 12 weeks|Change from baseline of plasma NO bioavailability, Change in plasma nitrite bioavailibility during heating, 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: University Hospital, Rouen | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
54
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-12
|
| Completion Date: |
2023-03-31
|
| Results First Posted: |
|
| Last Update Posted: |
2021-10-20
|
| Locations: |
Department of Nephrology, Bois-Guillaume, 76230, France|Department of Pharmacology, Rouen, 76031, France
|
| URL: |
https://clinicaltrials.gov/show/NCT04930549
|
