NCT01895140

A Study of Renal Denervation in Patients With Treatment Resistant Hypertension

A Pragmatic Randomized Clinical Evaluation of Renal Denervation for Treatment Resistant Hypertension

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Dr. Harindra Wijeysundera · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the clinical and economic impact of implementation of renal denervation with the Symplicity™ Catheter System for treatment-resistant hypertension in Ontario, Canada.

Detailed description

This is a pragmatic randomized trial of renal nerve denervation for treatment resistant hypertension. This is part of a ministry sponsored MaRS-EXCITE program, to conduct early market health technology assessment, in order to determine appropriateness for provincial funding. We will assess the effectiveness, safety, economic attractiveness and feasibility of implementation of renal nerve denervation for treatment resistant hypertension. This will involve a new model of care which will include a multi-disciplinary team approach to these patients. Treatment resistant hypertension is defined as patients with uncontrolled hypertension despite being on optimal doses of 3 or more anti-hypertensive medications. Patients will be randomized to either standard treatment or renal nerve denervation and followed for 6 months to determine impact on blood pressure.

Conditions

• Treatment-Resistant Hypertension

Interventions

Type	Name	Description
DEVICE	Renal denervation device

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2013-07-10
• Last updated: 2014-10-13

Locations

2 sites across 1 country: Canada