Clinical trial NCT01881035: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
Official title: Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension Secondary to Renal Disease
Keywords: Hypertension
End stage renal disease
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Oulu University Hospital
name: Satakunta Central Hospital
name: Central Finland Hospital District
name: Vaasa Central Hospital, Vaasa, Finland
First posted: 2013-06-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* pregnancy
* secondary hypertension
* unstable coronary artery disease

Primary outcomes:
measure: Comparison of blood pressures before and after intervention
timeFrame: 2 years
Secondary outcomes:
measure: Quality of life
timeFrame: 2 years
Other outcomes:
measure: 12-lead ECG changes
timeFrame: 2 years
Locations:
city: Vaasa
country: Finland
facility: Vaasa Central Hospital
Study officials:
References:
citation: Pietila-Effati PM, Salmela AK, Niemi RT, Ylitalo AS, Koistinen MJ. Renal sympathetic denervation in treating drug-resistant hypertension in a patient on hemodialysis. J Hypertens. 2016 Feb;34(2):368-70. doi: 10.1097/HJH.0000000000000802.