Renal Sympathetic Modification in Patients With Metabolic Syndrome

NCT ID: NCT01417247

Last Updated: 2019-03-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

renal sympathetic modification

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

Group Type: EXPERIMENTAL

renal sympathetic modification

Intervention Type: PROCEDURE

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

Absolute medicine therapy

Maintenance of anti-metabolic syndrome medications only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

renal sympathetic modification

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

Intervention Type: PROCEDURE

Other Intervention Names

renal denervation

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Chongqing Medical University

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuehui Yin

Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

2ndChongqingMU

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuehui Yin, MD

Role: CONTACT

yinyh63@163.com

0086-13508335502

Facility Contacts

Yuehui Yin, MD

Role: primary

yinyh63@163.com

0086-23-63693766

Other Identifiers

SWAN-MS

Identifier Type: -

Identifier Source: org_study_id