Renal Sympathetic Modification in Patients With Metabolic Syndrome

• Sponsor: The Second Affiliated Hospital of Chongqing Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01417247
• Collaborator: Jiangsu Provincial People's Hospital (Other), Chongqing Medical University (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 106
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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: Aug 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2019
• Anticipated Study Completion Date: Jun 1, 2020

Arms and Interventions

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 Names: renal denervation
No Intervention: Absolute medicine therapy Maintenance of anti-metabolic syndrome medications only

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	2ndChongqingMU	Chongqing	Chongqing	China	400010

Sponsors and Collaborators

• The Second Affiliated Hospital of Chongqing Medical University
• Jiangsu Provincial People's Hospital
• Chongqing Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None 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
• Other Study ID Numbers: SWAN-MS
• First Posted: Aug 16, 2011
• Last Update Posted: Mar 19, 2019
• Last Verified: Mar 1, 2019

• Keywords provided by 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: renal artery; sympathetic nerves; modification; metabolic syndrome
• Additional relevant MeSH terms: Metabolic Syndrome; Syndrome

Study Results

No Results Posted as of Mar 19, 2019