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Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension
Sponsor: Erasmus Medical Center
Summary
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
Official title: Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension: the RESTART Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2023-09-04
Completion Date
2030-09
Last Updated
2025-06-26
Healthy Volunteers
No
Conditions
Interventions
Paradise® ultrasound renal denervation system.
Bilateral renal sympathetic denervation of the native kidneys using the Paradise® ultrasound renal denervation system.
Locations (1)
Erasmus University Medical Center
Rotterdam, Netherlands