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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
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Physiologic response to denervation (e.g., blood pressure reduction) [ Time Frame: Through 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00753116

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

No publications provided

Responsible Party: Craig Straley, Ardian Inc.
ClinicalTrials.gov Identifier: NCT00753116     History of Changes
Other Study ID Numbers: TP-041
Study First Received: September 12, 2008
Last Updated: November 2, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013