Renal Sympathetic Modification in Patients With Metabolic Syndrome
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metabolic Syndrome |
Procedure: renal sympathetic modification |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Renal Sympathetic Modification in Patients With Metabolic Syndrome. |
- composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) [ Time Frame: three years ] [ Designated as safety issue: Yes ]
- effect of glucose and lipid metabolism, and blood pressure variability [ Time Frame: three years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: renal sympathetic modification
Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome.
|
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
|
|
No Intervention: Absolute medicine therapy
Maintenance of anti-metabolic syndrome medications only
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01417247
| Contact: Yuehui Yin, MD | 0086-13508335502 | yinyh63@163.com |
| China, Chongqing | |
| 2ndChongqingMU | Recruiting |
| Chongqing, Chongqing, China, 400010 | |
| Contact: Yuehui Yin, MD 0086-23-63693766 yinyh63@163.com | |
| Principal Investigator: Yuehui Yin, MD | |
More Information
No publications provided
| Responsible Party: | Yuehui Yin, Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center, The Second Affiliated Hospital of Chongqing Medical University |
| ClinicalTrials.gov Identifier: | NCT01417247 History of Changes |
| Other Study ID Numbers: | SWAN-MS |
| Study First Received: | August 15, 2011 |
| Last Updated: | May 2, 2013 |
| Health Authority: | China: Clinical Pharmacological Base of 2ndChongqingMU |
Keywords provided by The Second Affiliated Hospital of Chongqing Medical University:
|
renal artery sympathetic nerves modification metabolic syndrome |
Additional relevant MeSH terms:
|
Metabolic Syndrome X Syndrome Disease Glucose Metabolism Disorders |
Hyperinsulinism Insulin Resistance Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on March 01, 2015