Overview

Randomized Controlled Trial of Renal Denervation for Resistant Hypertension

Status:
Unknown status
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
Hypertension represents a significant global public health problem, contributing to vascular and renal morbidity, cardiovascular mortality, and economic burden. For a mostly asymptomatic disease, there is a huge challenge to maintain a good adherence and longtime persistence of drug use so as to adequately control it. Even so, a significant proportion of patients will develop resistant hypertension. In recent years, renal denervation has been argued as an effective means to address blood pressure problem in several non-Chinese clinical trials. The technique is to deliver low level radiofrequency energy through the renal artery wall to target the sympathetic nervous system and then modulate blood pressure. Shanghai WiseGain Medical Devices Co., LTD has developed the WiseGo Catheter System, which is an irrigated radiofrequency ablation Catheter. With this Catheter, it is expected to improve blood pressure status among patients with resistant hypertension failing polypharmacy. The purpose of this randomized control trial is to obtain an assessment of the efficacy and safety of WiseGo renal denervation technique in the presence of three standard antihypertensive medications in Chinese patients.
Phase:
Phase 3
Details
Lead Sponsor:
Shanghai WiseGain Medical Devices Co., Ltd.
Treatments:
Amlodipine
Antihypertensive Agents
Hydrochlorothiazide
Losartan