Renal Sympathetic Modification in Patients With Metabolic Syndrome

NCT01417247 | Unknown DMC

• 1 other identifier: SWAN-MS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

renal artery; sympathetic nerves; modification; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)

  three years

Secondary Outcomes (1)

• effect of glucose and lipid metabolism, and blood pressure variability

  three years

Study Arms (2)

renal sympathetic modification

EXPERIMENTAL

Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome.

Procedure: renal sympathetic modification

Absolute medicine therapy

NO INTERVENTION

Maintenance of anti-metabolic syndrome medications only

Interventions

renal sympathetic modification PROCEDURE

Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Also known as: renal denervation

renal sympathetic modification

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

2ndChongqingMU

Chongqing, Chongqing Municipality, 400010, China

RECRUITING

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Yuehui Yin, MD

CONTACT

0086-13508335502; yinyh63@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 16, 2011
• Study Start: August 1, 2011
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: March 19, 2019

Record last verified: 2019-03

Locations

CN (1)