Renal Denervation in Patients With Refractory Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Device: Renal Denervation

• Registration Number: NCT00753285
• Lead Sponsor: Medtronic Vascular

Brief Summary

The purpose of this study is to investigate the clinical utility of renal denervation for the treatment of 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: 2013-05
• Study Completion: 2013-05
• Disposition First Submitted: 2014-09-15
• Disposition First Submitted QC: 2014-09-15
• Disposition First Posted: 2014-09-29
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-03
• Last Update Posted: 2014-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Systolic blood pressure of 160 mmHg or greater
• On 3 or more antihypertensive medications
• eGFR >= 45 mL/min

Exclusion Criteria

• Renal artery abnormalities
• Known secondary hypertension attributable to a cause other than sleep apnea
• MI, angina, CVA within 6 months
• Type 1 diabetes
• Others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Renal Denervation	Renal Denervation	-

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 3 years

Secondary Outcome Measures

Name	Time	Method
Physiologic response to renal denervation (e.g., blood pressure reduction)	Through 3 years

Trial Locations

Locations (3)

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Prairie Heart Institute; 🇺🇸 Springfield, Illinois, United States

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