Renal Sympathetic Modification in Patients With Metabolic Syndrome
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ClinicalTrials.gov Identifier: NCT01417247 |
Recruitment Status
:
Recruiting
First Posted
: August 16, 2011
Last Update Posted
: July 17, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome | Procedure: renal sympathetic modification | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Renal Sympathetic Modification in Patients With Metabolic Syndrome. |
Actual Study Start Date : | August 2011 |
Estimated Primary Completion Date : | June 2019 |
Estimated Study Completion Date : | June 2020 |

Arm | Intervention/treatment |
---|---|
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
|
- composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) [ Time Frame: three years ]
- effect of glucose and lipid metabolism, and blood pressure variability [ Time Frame: three years ]

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 |
First Posted: | August 16, 2011 Key Record Dates |
Last Update Posted: | July 17, 2017 |
Last Verified: | July 2017 |
Keywords provided by Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University:
renal artery sympathetic nerves modification metabolic syndrome |
Additional relevant MeSH terms:
Syndrome Metabolic Syndrome X Disease Pathologic Processes |
Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |