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| Name | Class |
|---|---|
| Jiangsu Provincial People's Hospital | OTHER |
| Chongqing Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| renal sympathetic modification | Experimental | Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome. |
|
| Absolute medicine therapy | No Intervention | Maintenance of anti-metabolic syndrome medications only |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| renal sympathetic modification | Procedure | Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) | three years |
| Measure | Description | Time Frame |
|---|---|---|
| effect of glucose and lipid metabolism, and blood pressure variability | three years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuehui Yin, MD | Contact | 0086-13508335502 | yinyh63@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 2ndChongqingMU | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| D009750 |
| Nutritional and Metabolic Diseases |