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Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

Primary Purpose

End-stage Renal Disease, Hypertension

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Renal Denervation
Sponsored by
Baker Heart and Diabetes Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End-stage Renal Disease

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • end stage renal disease
  • hypertension (BP≥140/90mmHg)

Exclusion Criteria:

  • Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist.
  • Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.

Sites / Locations

  • Baker IDI Heart and Diabetes Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Renal Denervation

Usual Care

Arm Description

Renal denervation using a catheter-based Radio-frequency approach

Usual care

Outcomes

Primary Outcome Measures

Blood Pressure change
Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure

Secondary Outcome Measures

Full Information

First Posted
December 16, 2013
Last Updated
September 13, 2023
Sponsor
Baker Heart and Diabetes Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02021019
Brief Title
Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease
Official Title
Renal Denervation to Improve Outcomes in Patients With End-stage Renal
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2022 (Actual)
Study Completion Date
December 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baker Heart and Diabetes Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Sympathetic activation is a hallmark of end-stage renal disease and adversely affects cardiovascular prognosis. Hypertension is present in the vast majority of these patients and plays a key role in the progressive deterioration of renal function and in the exceedingly high rate of cardiovascular events. Selective catheter-based renal denervation has been shown to be safe and effective in attaining improved and sustained blood pressure control in patients with resistant hypertension and normal renal function. The investigators hypothesize that catheter-based renal denervation is a safe and effective intervention to achieve sustained reduction in sympathetic nerve activity, BP and target organ damage in hypertensive End-Stage Renal Disease (ESRD) patients, which will result in improved cardiovascular outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-stage Renal Disease, Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Renal Denervation
Arm Type
Experimental
Arm Description
Renal denervation using a catheter-based Radio-frequency approach
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care
Intervention Type
Procedure
Intervention Name(s)
Renal Denervation
Other Intervention Name(s)
Symplicity Renal Denervation Catheter
Intervention Description
Renal Denervation
Primary Outcome Measure Information:
Title
Blood Pressure change
Description
Difference in the reduction of systolic office blood pressure between the renal denervation and control group at 6 months after the procedure
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: end stage renal disease hypertension (BP≥140/90mmHg) Exclusion Criteria: Individual has renal artery anatomy that is ineligible for treatment as assessed by the interventionalist. Individual has experienced a myocardial infarction, unstable angina, or a cerebrovascular accident within 3 months of the screening visit.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus P Schlaich, MD
Organizational Affiliation
Baker Heart and Diabetes Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baker IDI Heart and Diabetes Institute
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

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Renal Denervation to Improve Outcomes in Patients With End-stage Renal Disease

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