NCT01560312

Renal Denervation in Refractory Hypertension

Renal Denervation - Hope for Patients With Refractory Hypertension?

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Charles University, Czech Republic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open, multicenter, randomized study is enrolling patients in 3 sites in Czech Republic. Patients with refractory hypertension will be randomized in 1:1 manner either to renal denervation plus optimal medical antihypertensive treatment without spironolactone or to antihypertensive treatment alone including spironolactone if not contraindicated. The primary end-point is change in Systolic and Diastolic Blood Pressure (BP) between baseline and 1 year after randomization evaluated by 24-hours BP monitoring. Expected enrollment is 120 patients. Patients follow-up is planned for 3 years.

Conditions

• Hypertension
• Resistant to Conventional Therapy

Interventions

Type	Name	Description
DEVICE	Renal denervation (Symplicity® Catheter System™)	4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)

Timeline

• Start date: 2011-10-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2012-03-22
• Last updated: 2019-02-01

Locations

3 sites across 1 country: Czechia