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

Primary Purpose

Hypertension Secondary to Renal Disease

Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Renal nerve denervation
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension Secondary to Renal Disease focused on measuring Hypertension, End stage renal disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • secondary hypertension
  • unstable coronary artery disease

Sites / Locations

  • Vaasa Central Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Renal nerve denervation

Arm Description

Renal nerve denervation

Outcomes

Primary Outcome Measures

Comparison of blood pressures before and after intervention

Secondary Outcome Measures

Quality of life

Full Information

First Posted
June 14, 2013
Last Updated
March 8, 2021
Sponsor
Turku University Hospital
Collaborators
Oulu University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT01881035
Brief Title
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
Acronym
TreatDialRDN
Official Title
Treatment of Resistant Hypertension by Renal Sympathetic Denervation in Patients Undergoing Dialysis Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruiting of the whole study population not possible.
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital
Collaborators
Oulu University Hospital, Satakunta Central Hospital, Central Finland Hospital District, Vaasa Central Hospital, Vaasa, Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension Secondary to Renal Disease
Keywords
Hypertension, End stage renal disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal nerve denervation
Arm Type
Experimental
Arm Description
Renal nerve denervation
Intervention Type
Procedure
Intervention Name(s)
Renal nerve denervation
Intervention Description
Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.
Primary Outcome Measure Information:
Title
Comparison of blood pressures before and after intervention
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
12-lead ECG changes
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with end stage renal disease and drug-resistant blood pressure. Exclusion Criteria: pregnancy secondary hypertension unstable coronary artery disease
Facility Information:
Facility Name
Vaasa Central Hospital
City
Vaasa
ZIP/Postal Code
65130
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26867061
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.
Results Reference
derived

Learn more about this trial

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

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