Renal Sympathetic Modification in Patients With Metabolic Syndrome

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Metabolic Syndrome	Procedure: renal sympathetic modification	Not Applicable

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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) [ Time Frame: three years ]

Secondary Outcome Measures :

1. effect of glucose and lipid metabolism, and blood pressure variability [ Time Frame: three years ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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 Locations

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Contacts

Contact: Yuehui Yin, MD	0086-13508335502	yinyh63@163.com

Locations

China, Chongqing
2ndChongqingMU	Recruiting
Chongqing, Chongqing, China, 400010
Contact: Yuehui Yin, MD 0086-23-63693766 yinyh63@163.com
Principal Investigator: Yuehui Yin, MD

Sponsors and Collaborators

The Second Affiliated Hospital of Chongqing Medical University

Jiangsu Provincial People's Hospital

Chongqing Medical University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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