Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

This study has been completed.

Sponsor:

Information provided by:

Medtronic Vascular

ClinicalTrials.gov Identifier:

NCT00753116

First received: September 12, 2008

Last updated: November 2, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 12, 2008
Last Updated Date	November 2, 2012
Start Date ^ICMJE	September 2008
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 15, 2008)	Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. [ Time Frame: Through 1 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00753116 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 15, 2008)	Physiologic response to denervation (e.g., blood pressure reduction) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Official Title ^ICMJE	Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Kidney Failure, Chronic Renal Dialysis
Intervention ^ICMJE	Device: Renal Denervation with a catheter-based procedure Disruption of the renal nerves with a catheter-based procedure
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	20
Completion Date	December 2009
Primary Completion Date	December 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00753116
Other Study ID Numbers ^ICMJE	TP-041
Has Data Monitoring Committee	Yes
Responsible Party	Craig Straley, Ardian Inc.
Study Sponsor ^ICMJE	Medtronic Vascular
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Vascular
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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