Metabolic Syndrome Study. Renal Sympathetic Denervation for Treatment of Metabolic Syndrome Associated Hypertensio

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 15

Inclusion Criteria

- Patient with office blood pressure *140/90 mmHg and 24-hour ambulatory blood pressure *130/80 mmHg at Enrollment despite treatment with two drugs at maximum tolerated doses
- Patient with a fasting glucose *100 mg/dL (*5.6 mmol/L) at Enrollment
- Patient with a waist circumference *102 cm (*40 inches) for male or *88 cm (*35 inches) for female at Enrollment
- Patient with any of the other metabolic syndrome diagnostic criteria listed as follows at Enrollment:
o Triglycerides *150 mg/dL (*1.7 mmol/L) or on drug treatment for elevated triglycerides
o High density lipid cholesterol (HDL-C) <40 mg/dL (<1.03 mmol/L) for male or <50 mg/dL
(<1.30 mmol/L) for female or on drug treatment for reduced HDL-C
- Patient is *18 and *80 years old
- Patient must be able and willing to provide written informed consent to participate in this clinical investigation
- Patient must be able and willing to comply with the required follow-up schedule

Exclusion Criteria

* Patient with resistant hypertension or secondary hypertension
* Patient with type I diabetes mellitus or type II diabetes mellitus requiring insulin therapy
* Patient with prior renal angioplasty, renal denervation, indwelling renal stents and/or
aortic stent grafts
* Patient with renal arteries <4.0 mm in diameter
* Patient with significant renovascular abnormalities (such as renal artery stenosis >30%)
* Patient with an estimated glomerular filtration rate (eGFR) of <45 mL/min per 1.73 m2
using the Modified Diet in Renal Disease (MDRD) formula
* Patient with hemodynamically significant valvular heart disease, as determined by Study
Investigator
* Patient has had a myocardial infarction, unstable angina pectoris or cerebrovascular
accident less than 180 days at Enrollment or is expected to have cardiovascular
intervention within the next 180 days
* Patient is in chronic atrial fibrillation/flutter or with severe conduction abnormalities or
with an implantable cardioverter defibrillator (ICD) or pacemaker whose settings cannot
allow for radiofrequency (RF) energy delivery
* Patient is currently being treated with drugs that cause salt retention (such as systemic
corticosteroids or fludrocortisone)
* Patient with an active systemic infection or blood-clotting abnormalities
* Patient is pregnant or of childbearing potential and is not using adequate contraceptive
methods or nursing
* Patient is participating in another clinical investigation
* Patient has a life expectancy less than 12 months, as determined by Study Investigator
* Patient has an allergy for contrast agent used for the angiogram

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the effects of renal sympathetic denervation on the insulin<br /><br>resistance and muscle sympathetic nerve activity (MSNA) in patients with<br /><br>metabolic syndrome and associated uncontrolled hypertension at 3 months after<br /><br>renal denervation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To determine the effects of renal sympathetic denervation on the insulin<br /><br>resistance, MSNA and blood pressure long-term (12 months after renal<br /><br>denervation).</p><br>