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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

September 12, 2008
November 2, 2012
September 2008
December 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00753116 on ClinicalTrials.gov Archive Site
Physiologic response to denervation (e.g., blood pressure reduction) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Failure, Chronic
  • Renal Dialysis
Device: Renal Denervation with a catheter-based procedure
Disruption of the renal nerves with a catheter-based procedure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00753116
TP-041
Yes
Craig Straley, Ardian Inc.
Medtronic Vascular
Not Provided
Not Provided
Medtronic Vascular
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP