NCT01417247

Renal Sympathetic Modification in Patients With Metabolic Syndrome

Renal Sympathetic Modification in Patients With Metabolic Syndrome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	renal sympathetic modification	Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure

Timeline

• Start date: 2011-08-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2011-08-16
• Last updated: 2019-03-19

Locations

1 site across 1 country: China