Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Study Overview
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Brief Summary
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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
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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.

Official Title
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Renal Denervation in Patients With Uncontrolled Hypertension in Chinese

Conditions
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Hypertension

Intervention / Treatment
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* Device: THERMOCOOL® Catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter, Renal Denervation, Ablation<br>Catheter-based renal denervation and maintenance of anti-hypertensive medications | Device: THERMOCOOL® Catheter<br>* Catheter-based renal denervation<br>|
| No Intervention: anti-hypertensive medications<br>Maintenance of anti-hypertensive medications | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Reduction | To confirm that renal denervation is safe, feasible and effective. | one year |