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NCT00753116 Clinical Trial

Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Kidney Failure, Chronic Clinical Trial

Official title:
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00753116
Other study ID # TP-041
Secondary ID
Status Completed
Phase Phase 1
First received September 12, 2008
Last updated November 2, 2012
Start date September 2008
Est. completion date December 2009

Study information
Verified date November 2012
Source Medtronic Vascular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Renal Denervation with a catheter-based procedure
Disruption of the renal nerves with a catheter-based procedure

Locations
Country Name City State
United States Hennepin County Medical Center Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Medtronic Vascular

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events. Through 1 year Yes
Secondary Physiologic response to denervation (e.g., blood pressure reduction) Through 1 year No
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