NL-OMON41209撤回不适用
Metabolic Syndrome Study. Renal Sympathetic Denervation for Treatment of Metabolic Syndrome. - Metabolic Syndrome Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patient with office blood pressure *140/90 mmHg and 24-hour ambulatory blood pressure *130/80 mmHg at Baseline despite the stable use of at least two anti-hypertensive drugs at maximum tolerated doses of the patient for at least 4 weeks
- •- Patient with a fasting glucose *100 mg/dL (*5.6 mmol/L) at Baseline or on drug treatment for elevated glucose
- •- Patient with a waist circumference *102 cm (*40 inches) for male or *88 cm (*35 inches) for female at Baseline
- •- Patient with any of the remaining two metabolic syndrome diagnostic criteria listed as follows at Baseline:
- •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 *70 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
排除标准
- •- Patient with 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 Baseline 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), centrally acting sympatholytic antihypertensive drugs, direct vasodilators (such as alpha blockers) an continious positive airway pressure (CPAP) therapy for obstuctive sleep apnea.
- •- Patient with an active systemic infection or blood-clotting abnormalities or allergy to radiographic contrast
- •- 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
研究者
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