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Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00753116
First Posted: September 16, 2008
Last Update Posted: November 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Medtronic Vascular
  Purpose
The purpose of this this study is to investigate the clinical utility of renal denervation in the treatment of ESRD patients with refractory hypertension.

Condition Intervention Phase
Kidney Failure, Chronic Renal Dialysis Device: Renal Denervation with a catheter-based procedure Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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 Measures:
  • Physiologic response to denervation (e.g., blood pressure reduction) [ Time Frame: Through 1 year ]

Estimated Enrollment: 20
Study Start Date: September 2008
Study Completion Date: December 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Renal Denervation with a catheter-based procedure
    Disruption of the renal nerves with a catheter-based procedure
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753116


Locations
United States, Minnesota
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Sponsors and Collaborators
Medtronic Vascular
  More Information

Responsible Party: Craig Straley, Ardian Inc.
ClinicalTrials.gov Identifier: NCT00753116     History of Changes
Other Study ID Numbers: TP-041
First Submitted: September 12, 2008
First Posted: September 16, 2008
Last Update Posted: November 6, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Hypertension
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic