NCT02346045

Effect of Renal Denervation in End Staged Renal Disease With Resistant Hypertension

Effects of Catheter Based Renal Sympathetic Denervation on Resistant Hypertension in End Stage Renal Disease in Korea

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

A. Hypertension is a major cardiovascular risk factor and numerous treatment strategies have been developed to treat hypertension properly and reduce cardiovascular risk. B. However, there is a subgroup of hypertension which are resistant to treatment. 1. Resistant hypertension is associated to sympathetic hyperactivity 2. Renal sympathetic nerve is known to be associated with systemic sympathetic activity 3. According to research of recent years, catheter based renal sympathetic denervation is a safe and effective treatment modality to treat resistant hypertension C. Resistant hypertension is observed in end stage renal disease (ESRD) frequently. D. Sympathetic hyperactivity is observed in ESRD patients E. Catheter based renal sympathetic denervation is expected to improve resistant hypertension in ESRD patients F. The aim the present study is to evaluate the effects and safety of catheter based renal sympathetic denervation on resistant hypertension in ESRD

Conditions

• Hypertension

Interventions

Type	Name	Description
PROCEDURE	Renal sympathetic denervation	In the experimental arm, Intervention is renal sympathetic denervation using Symplicity® system (Medtronic Ardian Inc, Mountain View, CA, USA) and antihypertensive medications previously prescribed 1. After femoral puncture guiding catheter is engaged in renal artery 2. Symplicity radiofrequency ablation catheter is inserted into renal artery and by circular sequence, from distal to proximal portion, ablation energy is applied to the wall of renal artery 3. 4-5 ablations are applied in each renal artery. In the sham comparator, intervention is renal angiogram and continue antihypertensive medications previuosly decribed

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2018-10-01
• First posted: 2015-01-26
• Last updated: 2015-01-26

Locations

4 sites across 1 country: South Korea