Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension

Phase 1

Completed

• Conditions: Kidney Failure, Chronic; Renal Dialysis

• Registration Number: NCT00753116
• Lead Sponsor: Medtronic Vascular

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 available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-09-12
• Study First Submitted QC: 2008-09-15
• Study First Posted: 2008-09-16
• Primary Completion: 2008-12
• Study Completion: 2009-12
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-02
• Last Update Posted: 2012-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety - complications associated with delivery and/or use of the Ardian Catheter, adverse renal events, electrolyte disturbances, hemodynamic events.	Through 1 year

Secondary Outcome Measures

Name	Time	Method
Physiologic response to denervation (e.g., blood pressure reduction)	Through 1 year

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States