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

Not Applicable

Terminated

• Conditions: Hypertension Secondary to Renal Disease
• Interventions: Procedure: Renal nerve denervation

• Registration Number: NCT01881035
• Lead Sponsor: Turku University Hospital

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 Description

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.

Study Timeline

• Study Start: 2013-05-01
• Study First Submitted: 2013-06-14
• Study First Submitted QC: 2013-06-18
• Study First Posted: 2013-06-19
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-08
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• patients with end stage renal disease and drug-resistant blood pressure.

Exclusion Criteria

• pregnancy
• secondary hypertension
• unstable coronary artery disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal nerve denervation	Renal nerve denervation	Renal nerve denervation

Primary Outcome Measures

Name	Time	Method
Comparison of blood pressures before and after intervention	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of life	2 years

Trial Locations

Locations (1)

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland