Renal Denervation in Patients With Uncontrolled Hypertension in Chinese
The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Renal Denervation in Patients With Uncontrolled Hypertension in Chinese|
- Blood Pressure Reduction [ Time Frame: one year ] [ Designated as safety issue: Yes ]To confirm that renal denervation is safe, feasible and effective.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Catheter, Renal Denervation, Ablation
Catheter-based renal denervation and maintenance of anti-hypertensive medications
Device: THERMOCOOL® Catheter
Catheter-based renal denervation
No Intervention: anti-hypertensive medications
Maintenance of anti-hypertensive medications
Prevalence of hypertension is increasing in China.While actually,the controlled rate of hypertension is relatively low,though numerous safe and effective pharmacological therapies are used in clinical practice.Studies confirmed that renal sympathetic nerves contributed to development and perpetuation of hypertension. Previous study has stated that renal denervation was effective and safe in patients with resistant hypertension, while little data is known in Chinese patients. We hypothesis that renal denervation is effective and safe in treatment of Chinese patients with uncontrolled hypertension. This trial plan to recruit 100 patients(Ablation group VS Control group = 1:1) with a follow up duration of 3 years.Patients in ablation group will receive percutaneous renal denervation combined with necessary antihypertension drugs and patients in control group will receive appropriate antihypertension drugs. We aim to explore the long term safety and validity of renal denervation in Chinese patients with uncontrolled hypertension.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01390831
|Contact: Jian Xiong Liu, MDfirstname.lastname@example.org|
|Principal Investigator:||Jian Xiong Liu||The Second People's Hospital of Chengdu|