Back to resultsRenal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Primary Purpose
Kidney Failure, Chronic, Renal Dialysis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Renal Denervation with a catheter-based procedure
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Failure, Chronic
Eligibility Criteria
Inclusion Criteria:
- Systolic blood pressure of 160 mmHg or greater
- On 3 or more antihypertensive medications
- On dialysis for more than 6 months
Exclusion Criteria:
- Renal artery abnormalities
- Known secondary hypertension attributable to a cause other than sleep apnea
- MI, angina, CVA within 6 months
- Others
Sites / Locations
- Hennepin County Medical Center
Outcomes
Primary Outcome Measures
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Secondary Outcome Measures
Physiologic response to denervation (e.g., blood pressure reduction)
Full Information
NCT ID
NCT00753116
First Posted
September 12, 2008
Last Updated
November 2, 2012
Sponsor
Medtronic Vascular
1. Study Identification
Unique Protocol Identification Number
NCT00753116
Brief Title
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Official Title
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medtronic Vascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Chronic, Renal Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Renal Denervation with a catheter-based procedure
Intervention Description
Disruption of the renal nerves with a catheter-based procedure
Primary Outcome Measure Information:
Title
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.
Time Frame
Through 1 year
Secondary Outcome Measure Information:
Title
Physiologic response to denervation (e.g., blood pressure reduction)
Time Frame
Through 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Systolic blood pressure of 160 mmHg or greater
On 3 or more antihypertensive medications
On dialysis for more than 6 months
Exclusion Criteria:
Renal artery abnormalities
Known secondary hypertension attributable to a cause other than sleep apnea
MI, angina, CVA within 6 months
Others
Facility Information:
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
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