Metabolic Syndrome
Conditions
Keywords
renal artery, sympathetic nerves, modification, metabolic syndrome
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.
Interventions
PROCEDURErenal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Sponsors
Jiangsu Provincial People's Hospital
Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) | three years |
Secondary
| Measure | Time frame |
|---|---|
| effect of glucose and lipid metabolism, and blood pressure variability | three years |
Countries
China
Contacts
Primary ContactYuehui Yin, MD
Outcome results
None listed