Renal Sympathetic Modification in Patients With Essential Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Renal Sympathetic Modification in Patients With Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Procedure: renal sympathetic modification


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years old, and ≤ 75 years old of age more than half a year history of hypertension, except for valvular heart disease recently at least three times office blood pressure suggest systolic blood pressure of 140mmHg or more and/or a diastolic blood pressure of 90mmHg or more estimated glomerular filtration rate (eGFR) of ≥ 45mL/min is competent and willing to provide written, informed consent to participate in this clinical study Exclusion Criteria: secondary hypertension isolated systolic hypertension estimated glomerular filtration rate (eGFR) of < 45mL/min has the history of renal restenosis or renal stents implantation has experienced AMI (old myocardial infarction is not excluded), unstable angina pectoris, cerebrovascular accidents, and alimentary tract hemorrhage within 3 months patients with sick sinus syndrome pregnant women mental disorders patients that have allergy to contrast agent patients that do not go with follow-up others such as researcher considers it is not appropriate to be included into the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal sympathetic modification<br>Renal artery ablation to modify sympathetic activity in patients with essential hypertension. | Procedure: renal sympathetic modification<br>* Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure<br>* Other names: renal denervation;|
| No Intervention: Absolute medicine therapy<br>Maintenance of anti-hypertensive medications only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite cardiovascular events | Comprising myocardial infarction, stroke, heart failure, sudden death | three years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal artery, sympathetic nerves, modification, essential hypertension, primary hypertension