Renal Sympathetic Modification in Patients With Metabolic Syndrome.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)
- Last Updated
- 7 years ago
Overview
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.
Investigators
Yuehui Yin
Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
The Second Affiliated Hospital of Chongqing Medical University
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
Outcomes
Primary Outcomes
composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)
Time Frame: three years
Secondary Outcomes
- effect of glucose and lipid metabolism, and blood pressure variability(three years)