Clinical Trial: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy

Brief Summary: The study is designed to investigate the efficacy of renal nerve denervation in treating drug-resistant hypertension in patients with end stage renal disease.

Detailed Summary: Drug resistant hypertension is very common in end stage renal disease treated by dialysis. The prevalence of hypertension has been evaluated to be over 50% and up 80%. In this patient group mortality figures are high because of cardiovascular diseases which are complications of hypertension. Renal nerve denervation is a new intervention to treat hypertension. By applying radiofrequency pulses to the renal arteries, the nerves in the vascular wall (adventitia layer) can be denervated. This causes reduction of renal sympathetic afferent and efferent activity and blood pressure can be decreased. The technique and its efficacy in end stage renal disease has not been systematically studied. There are case reports which have showed promising responses to denervation. In the present study 30 patients over 18 years are planned undergo renal denervation if the medical treatment (three different drugs including diuretics) has failed to decrease blood pressure sufficiently(160/100mmHg). The failure of medical treatment will be documented by ambulatory blood pressure measurements. After renal nerve denervation a two year follow-up of patients with ambulatory blood pressure measurements will be organized. The blood pressures before and after denervation are compared and the quality of life of the patients is evaluated by questionnaires.
Sponsor: Turku University Hospital

Current Primary Outcome: Comparison of blood pressures before and after intervention [ Time Frame: 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life [ Time Frame: 2 years ]

Original Secondary Outcome: Ouality of life [ Time Frame: 2 years ]

Information By: Turku University Hospital

Dates:
Date Received: June 14, 2013
Date Started: May 2013
Date Completion: December 2016
Last Updated: September 22, 2016
Last Verified: September 2016