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Renal Sympathetic Modification in Patients With Metabolic Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by The Second Affiliated Hospital of Chongqing Medical University
Sponsor:
Collaborators:
Jiangsu Provincial People's Hospital
Chongqing Medical University
Information provided by (Responsible Party):
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier:
NCT01417247
First received: August 15, 2011
Last updated: May 2, 2013
Last verified: May 2013

August 15, 2011
May 2, 2013
August 2011
December 2015   (final data collection date for primary outcome measure)
composite cardiovascular events (myocardial infarction, heart failure, sudden death, cardiogenic death) [ Time Frame: three years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01417247 on ClinicalTrials.gov Archive Site
effect of glucose and lipid metabolism, and blood pressure variability [ Time Frame: three years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Renal Sympathetic Modification in Patients With Metabolic Syndrome
Renal Sympathetic Modification in Patients With Metabolic Syndrome.

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metabolic Syndrome
Procedure: renal sympathetic modification
Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
Other Name: renal denervation
  • Experimental: renal sympathetic modification
    Renal artery ablation to modify sympathetic activity in patients with metabolic syndrome.
    Intervention: Procedure: renal sympathetic modification
  • No Intervention: Absolute medicine therapy
    Maintenance of anti-metabolic syndrome medications only
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2016
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact: Yuehui Yin, MD 0086-13508335502 yinyh63@163.com
China
 
NCT01417247
SWAN-MS
Yes
Yuehui Yin, The Second Affiliated Hospital of Chongqing Medical University
The Second Affiliated Hospital of Chongqing Medical University
  • Jiangsu Provincial People's Hospital
  • Chongqing Medical University
Not Provided
The Second Affiliated Hospital of Chongqing Medical University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP