Renal Sympathetic Modification in Patients With Metabolic Syndrome

Chongqing Medical University

Status

Unknown

Conditions

Metabolic Syndrome

Treatments

Procedure: renal sympathetic modification

Study type

Interventional

Funder types

Other

Identifiers

NCT01417247

SWAN-MS

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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