Renal Sympathetic Denervation for Treatment of Metabolic Syndrome Associated Hypertension (Metabolic Syndrome Study)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified July 2013 by St. Jude Medical
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01911078
First received: July 24, 2013
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on the insulin resistance, muscle sympathetic nerve activity and blood pressure in patients with metabolic syndrome and associated uncontrolled hypertension.


Condition Intervention
Metabolic Syndrome
Uncontrolled Hypertension
Procedure: Renal Denervation
Device: EnligHTN™ Renal Denervation System.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Renal Sympathetic Denervation for Treatment of Metabolic Syndrome Associated Hypertension (Metabolic Syndrome Study)

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Change in insulin resistance from baseline to 3 months after renal denervation [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
    To determine the effects of renal sympathetic denervation on the insulin resistance (determined by the Homeostasis Model Assessment - Insulin Resistance method) at 3 months after renal denervation


Secondary Outcome Measures:
  • Change in insulin resistance from baseline to 12 months after renal denervation [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    To determine the effects of renal sympathetic denervation on the insulin resistance long-term (12 months after renal denervation).

  • Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months and 12 months after renal denervation [ Time Frame: Baseline, Month 3 and Month 12 ] [ Designated as safety issue: No ]
    To determine the effects of renal sympathetic denervation on the MSNA at 3 months and 12 months after renal denervation

  • Change in blood pressure from baseline to 12 months after renal denervation [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    To determine the effects of renal sympathetic denervation on the blood pressure long-term (12 months after renal denervation).


Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Renal Denervation Group
Subjects receiving renal denervation procedure.
Procedure: Renal Denervation
Renal artery ablation with the EnligHTN™ Renal Denervation System.
Device: EnligHTN™ Renal Denervation System.
No Intervention: Control Group

Subjects not receiving renal denervation procedure.

Subjects are randomized in a 3:1 ratio to either Treatment Group or Control Group.


  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

    • Triglycerides ≥150 mg/dL (≥1.7 mmol/L) or on drug treatment for elevated triglycerides
    • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01911078

Contacts
Contact: Elizabeth Lau, PhD elau@sjm.com

Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01911078     History of Changes
Other Study ID Numbers: CI-12-079-EU-RD
Study First Received: July 24, 2013
Last Updated: July 29, 2013
Health Authority: Greece: Ethics Committee

Keywords provided by St. Jude Medical:
Metabolic syndrome
Uncontrolled hypertension
Renal denervation
Renal artery

Additional relevant MeSH terms:
Hypertension
Metabolic Syndrome X
Vascular Diseases
Cardiovascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014