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

Hypertension Secondary to Renal Disease Clinical Trial

— TreatDialRDN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01881035
• Other study ID #: VCH Heart Station 10
• Secondary ID: TreatDialRDN (II
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: March 2021
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

• secondary hypertension

• unstable coronary artery disease

Related Conditions & MeSH terms

• Hypertension
• Hypertension Secondary to Renal Disease
• Kidney Diseases

Intervention

Procedure:
• Renal nerve denervation
Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.

Locations

Country	Name	City	State
Finland	Vaasa Central Hospital	Vaasa

Sponsors (5)

Lead Sponsor	Collaborator
Turku University Hospital	Central Finland Hospital District, Oulu University Hospital, Satakunta Central Hospital, Vaasa Central Hospital, Vaasa, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	12-lead ECG changes		2 years
Primary	Comparison of blood pressures before and after intervention		2 years
Secondary	Quality of life		2 years