NL-OMON40213
Withdrawn
Not Applicable
Metabolic Syndrome Study. Renal Sympathetic Denervation for Treatment of Metabolic Syndrome Associated Hypertension - Metabolic Syndrome Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- St. Jude Medical
- Enrollment
- 15
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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:
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Withdrawn
Not Applicable
Metabolic Syndrome Study. Renal Sympathetic Denervation for Treatment of Metabolic Syndrome.Metabool SyndroomMetabolic Syndrome - insulin resistance syndrome10057166NL-OMON41209St. Jude Medical15
Completed
Not Applicable
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)Metabolic SyndromeNCT01911078Abbott Medical Devices20
Withdrawn
Phase 4
Renal Sympathetic Denervation in patients with therapy-resistant Catecholamine Polymorphic Ventricular Tachycardia (CPVT) and Long QT Syndrome (LQTS) * RESIDENT StudyNL-OMON41010Academisch Medisch Centrum20
Withdrawn
Phase 4
Renal Sympathetic Denervation after Renal Transplantation Study - IHypertension10057166NL-OMON37506eids Universitair Medisch Centrum10
Completed
Phase 3
Denervation of the REnal Artery in Metabolic SyndromeInsulin ResistanceBlood PressureNCT01465724UMC Utrecht29