Renal Sympathetic Modification in Patients With Essential Hypertension
The purpose of this study is to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with essential hypertension, and evaluate safety and efficacy of the intervention.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Renal Sympathetic Modification in Patients With Essential Hypertension|
- composite cardiovascular events [ Time Frame: three years ] [ Designated as safety issue: Yes ]Comprising myocardial infarction, stroke, heart failure, sudden death
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with essential hypertension.
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
No Intervention: Absolute medicine therapy
Maintenance of anti-hypertensive medications only
Hypertension is a common cardiovascular disease, and is also an important risk factor for heart-brain-renal diseases, with relatively low controlled rate. Traditional pharmacological therapies are used in clinical practice without breakthrough for long time. Previous studies confirmed that sympathetic nerves activity contributed to development and perpetuation of hypertension. Renal ablation for sympathetic modification is a new method which is proved to be effective in decreasing sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of hypertension. This trial is going to recruit 200 patients (Ablation group VS Control group = 1:1) with a follow-up duration of 3 years. Patients in ablation group will receive additional necessary anti-hypertensive medications besides expectant intervention, and patients in control group will receive appropriate anti-hypertensive medications only. We aim to observe the incident of composite cardiovascular events after renal sympathetic modification using THERMOCOOL® catheter in patients with hypertension, and evaluate safety and efficacy of the intervention.
|Contact: Yuehui Yin, MDfirstname.lastname@example.org|
|Chongqing, Chongqing, China, 400010|
|Contact: Yuehui Yin, MD 0086-23-63693766 email@example.com|
|Principal Investigator: Yuehui Yin, MD|