Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Phase 1

• Conditions: Hypertension
• Interventions: Device: THERMOCOOL® Catheter

• Registration Number: NCT01390831
• Lead Sponsor: The Second People's Hospital of Chengdu

Brief Summary

The purpose of this study is to determine whether renal denervation is safe and effective in the treatment of Chinese patients with uncontrolled hypertension.

Detailed Description

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.

Study Timeline

• Status Verified: 2011-04
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-08
• Last Update Submitted: 2011-07-08
• Study First Posted: 2011-07-11
• Last Update Posted: 2011-07-11
• Study Start: 2011-11
• Primary Completion: 2014-11
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• >= 18 years of age
• a systolic blood pressure of 160mmHg or more and/or a diastolic blood pressure of 90mmHg or more
• receiving and adhering to at least three full doses of appropriate antihypertensive drug regimen
• estimated glomerular filtration rate (eGFR) of ≥45mL/min
• agrees to have the study procedure(s) performed and additional procedures and evaluations
• is competent and willing to provide written, informed consent to participate in this clinical study

Exclusion Criteria

• secondary hypertension
• renal arterial abnormalities
• has experienced MI, unstable angina pectoris, or CVA within 6 months
• has an implantable cardioverter defibrillator (ICD) or pacemaker, or any other metallic implant which is not compatible with magnetic resonance imaging (MRI)
• requires respiratory support
• patients with sick sinus syndrome
• pregnant woman
• others

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter, Renal Denervation, Ablation	THERMOCOOL® Catheter	Catheter-based renal denervation and maintenance of anti-hypertensive medications

Primary Outcome Measures

Name	Time	Method
Blood Pressure Reduction	one year	To confirm that renal denervation is safe, feasible and effective.