Renal Sympathetic Modification in Patients With Metabolic Syndrome

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 metabolic syndrome, and evaluate safety and efficacy of the intervention.

Detailed Description
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Metabolic syndrome is combination risk factors of serial cardiovascular and metabolic disease, included central obesity, insulin resistance, dyslipidemia, and hypertension. Basic studies suggested that sympathetic nerves over activity played an important role in the development and perpetuation of metabolic syndrome. Clinical therapies occurred by complication treatment and therapeutic life-style changes. Present study of renal ablation for sympathetic modification shows a new method to decrease sympathetic nerves activity. We assume that modifying renal sympathetic activity by ablation is effective and safe in treatment of metabolic syndrome. 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 medications besides expectant intervention, and patients in control group will receive appropriate 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 Metabolic Syndrome.

Conditions
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Metabolic Syndrome

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 abnormal metabolism: 1) body mass index (BMI) of ≥ 25 kg/m2; 2) total triglyceride (TG) of ≥ 1.70mmol/l (150mg/dl); 3) high density lipoprotein- cholesterol (HDL-C) of male <0.91mmol/l (35mg/dl), and of female <1.01mmol/l (39mg/dl); 4)fasting blood glucose 6.1mmol/l (110mg/dl), or glucose tolerance test of 2 hours ≥ 7.8 mmol/l (140mg/dl); 5), or history of diabetes mellitus 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 type 1 diabetes mellitus 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 metabolic syndrome. | 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-metabolic syndrome medications only | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) |  | three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of glucose and lipid metabolism, and blood pressure variability |  | 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, metabolic syndrome