RDN-CKD GR Study is a prospective, randomized (1:1), double-blind (unblinded interventionalist and blinded study team), sham controlled study. The purpose of the RDN-CKD GR Study is to demonstrate that renal denervation (RDN) effectively reduces 24-h ambulatory BP in 20 patients with chronic kidney disease (CKD) stage 3a or 3b.
Inclusion Criteria:
Exclusion Criteria:
The subjects and all study personnel taking BP measurements will be blinded to the randomization. Subjects will complete a blinding assessment prior to hospital pre-discharge and at 3 weeks, 6 months and 12 months FU.
All subjects will undergo a diagnostic computed tomography angiography (CTA) or magnetic resonance angiography (MRA) of renal arteries, and a pre-procedural renal angiogram (based on clinical grounds to rule out renal artery stenosis and confirm eligibility criteria) which should be per Institutional practice via femoral artery access. Randomization will occur following the diagnostic renal angiogram. If randomized to the Renal Denervation Group RDN procedure will be applied using the Paradise® Renal Denervation System. The Paradise® Renal Denervation System is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.
All subjects will undergo a diagnostic computed tomography angiography (CTA) or magnetic resonance angiography (MRA) of the renal arteries, followed by a pre-procedural renal angiogram (based on clinical grounds to rule out renal artery stenosis and confirm eligibility criteria) which should be per Institutional practice via femoral artery access. Randomization will occur following the diagnostic renal angiogram. In these patients no RDN will be performed.
Athens, 11527, Greece
Renal Denervation in Chronic Kidney Disease - RDN-CKD Study
Effect of Renal Denervation on Bood Pressure in Patients on Hemodialysis
Renal Denervation for Complicated Hypertension
Renal Denervation in ADPKD- RDN-ADPKD Study
Efficacy and Safety of Renal Denervation on Isolated Diastolic Hypertension
Renal Protection Using Sympathetic Denervation in Patients With Chronic Kidney Disease
Renal Denervation for Uncontrolled Hypertension
Renal Denervation on Quality of 24-hr BP Control by Ultrasound In Resistant Hypertension