Renal Sympathetic Modification in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Renal Sympathetic Modification in Patients With Metabolic Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01417247
• Other study ID #: SWAN-MS
• Status: Recruiting
• Phase: N/A
• Start date: August 2011
• Est. completion date: June 2020

Study information

• Verified date: March 2019
• Source: The Second Affiliated Hospital of Chongqing Medical University
• Contact: Yuehui Yin, MD
• Phone: 0086-13508335502
• Email: yinyh63[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
China	2ndChongqingMU	Chongqing	Chongqing

Sponsors (3)

Lead Sponsor	Collaborator
The Second Affiliated Hospital of Chongqing Medical University	Chongqing Medical University, Jiangsu Provincial People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)		three years
Secondary	effect of glucose and lipid metabolism, and blood pressure variability		three years