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RECRUITING
NCT05934383
NA

Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

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

Interventions

DEVICE

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