A Study of Renal Denervation in Patients With Treatment Resistant Hypertension — PaCE  

Treatment-Resistant Hypertension Clinical Trial

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

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension
• Treatment-Resistant Hypertension

• NCT number: NCT01895140
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Completion date: October 2014