Back to resultsRenal Sympathetic Modification in Patients With Metabolic Syndrome
Primary Purpose
Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
renal sympathetic modification
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome focused on measuring renal artery, sympathetic nerves, modification, metabolic syndrome
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
Sites / Locations
- 2ndChongqingMURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
renal sympathetic modification
Absolute medicine therapy
Arm Description
Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome.
Maintenance of anti-metabolic syndrome medications only
Outcomes
Primary Outcome Measures
composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)
Secondary Outcome Measures
effect of glucose and lipid metabolism, and blood pressure variability
Full Information
NCT ID
NCT01417247
First Posted
August 15, 2011
Last Updated
March 18, 2019
Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01417247
Brief Title
Renal Sympathetic Modification in Patients With Metabolic Syndrome
Official Title
Renal Sympathetic Modification in Patients With Metabolic Syndrome.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Second Affiliated Hospital of Chongqing Medical University
Collaborators
Jiangsu Provincial People's Hospital, Chongqing Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
Keywords
renal artery, sympathetic nerves, modification, metabolic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
renal sympathetic modification
Arm Type
Experimental
Arm Description
Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome.
Arm Title
Absolute medicine therapy
Arm Type
No Intervention
Arm Description
Maintenance of anti-metabolic syndrome medications only
Intervention Type
Procedure
Intervention Name(s)
renal sympathetic modification
Other Intervention Name(s)
renal denervation
Intervention Description
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Primary Outcome Measure Information:
Title
composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death)
Time Frame
three years
Secondary Outcome Measure Information:
Title
effect of glucose and lipid metabolism, and blood pressure variability
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuehui Yin, MD
Phone
0086-13508335502
Email
yinyh63@163.com
Facility Information:
Facility Name
2ndChongqingMU
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
Phone
0086-23-63693766
Email
yinyh63@163.com
First Name & Middle Initial & Last Name & Degree
Yuehui Yin, MD
12. IPD Sharing Statement
Learn more about this trial
Renal Sympathetic Modification in Patients With Metabolic Syndrome
We'll reach out to this number within 24 hrs