Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
This prospective, single-arm, interventional study is designed to assess the short-term and long-term safety and efficacy of bilateral ultrasound renal sympathetic denervation (RDN) of the native kidneys in renal transplant patients with uncontrolled hypertension. Objectives: * To assess the short-term and long-term changes in ambulatory and office blood pressure (BP) following native kidney RDN in renal transplant patients * To assess the long-term safety of native kidney RDN in renal transplant patients * To…
Conditions studied
Hypertension, Kidney Transplantation
About this study
This prospective, single-arm, interventional study is designed to assess the short-term and long-term safety and efficacy of bilateral ultrasound renal sympathetic denervation (RDN) of the native kidneys in renal transplant patients with uncontrolled hypertension. Objectives: * To assess the short-term and long-term changes in ambulatory and office blood pressure (BP) following native kidney RDN in renal transplant patients * To assess the long-term safety of native kidney RDN in renal transplant patients * To assess the short-term and long-term change in antihypertensive drug prescriptions following native kidney RDN in renal transplant patients * To assess the short-term and long-term change in adherence to antihypertensive drugs following native kidney RDN in renal transplant patients
Interventions
- Device: Paradise® ultrasound renal denervation system. — Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.
Primary outcomes
- Efficacy: change in mean 24-hour ambulatory systolic blood pressure (Baseline vs. 3-month follow-up)
- Safety: occurrence of the composite endpoint (Baseline vs. 3-month follow-up)
Eligibility information
Study locations
- Erasmus University Medical Center, Rotterdam, Netherlands
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-15.