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

NCT ID: NCT01881035

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-01
• Study Completion Date: 2016-12-31

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.

Conditions

Hypertension Secondary to Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal nerve denervation

Renal nerve denervation

Group Type: EXPERIMENTAL

Renal nerve denervation

Intervention Type: PROCEDURE

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

Interventions

Renal nerve denervation

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• secondary hypertension
• unstable coronary artery disease

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oulu University Hospital

OTHER

Sponsor Role: collaborator

Satakunta Central Hospital

OTHER

Sponsor Role: collaborator

Central Finland Hospital District

OTHER

Sponsor Role: collaborator

Vaasa Central Hospital, Vaasa, Finland

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Juhani Koistinen

Professor in Medicine Turku University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vaasa Central Hospital

Vaasa, , Finland

Countries

Finland

References

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.

Reference Type: DERIVED

PMID: 26867061 (View on PubMed)

Other Identifiers

TreatDialRDN (II)

Identifier Type: OTHER

Identifier Source: secondary_id

VCH Heart Station 10

Identifier Type: -

Identifier Source: org_study_id