NCT01850901

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension

Renal Sympathetic Denervation as a New Treatment for Therapy Resistant Hypertension - A Multicenter Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess whether renal denervation (RD) added to usual care compared to usual care alone reduces blood pressure (BP) as determined with ambulatory BP monitoring (ABPM) after 6 months in subjects with an average day-time systolic BP of at least 135 mmHg as determined with use of ABPM, despite use of three or more BP lowering agents or with documented intolerance or contraindication for to 2 or more of the 4 major classes of antihypertensive drugs (ACEi/ARB, calcium channel blockers, betablockers and diuretics) obstructing use of 3 antihypertensives Further aims are to assess the effect of renal denervation on the use of BP lowering agents, to explore the effect of renal denervation in strata of estimated glomerular filtration rate (eGFR) (eGFR 20-60 mL/min per 1.73m2 and eGFR\>60 mL/min per 1.73m2) and according to baseline office BP. Randomization will be stratified by hospital and eGFR and will be at a 2:1 ratio.

Conditions

• Hypertension
• Chronic Kidney Disease

Interventions

Type	Name	Description
PROCEDURE	Renal sympathetic denervation

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2013-05-10
• Last updated: 2017-02-01

Locations

1 site across 1 country: Netherlands