NCT01911078已完成不适用
Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in insulin resistance from baseline to 3 months after renal denervation
研究概览
简要总结
The purpose of this clinical investigation is to determine the effects of renal sympathetic denervation on insulin resistance and muscle sympathetic nerve activity in patients with metabolic syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
- •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 ≤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) and continuous positive airway pressure (CPAP) therapy for obstructive 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
研究组 & 干预措施
Renal Denervation Group
Other
Subjects receiving renal denervation procedure.
干预措施: Renal Denervation (Procedure)
Renal Denervation Group
Other
Subjects receiving renal denervation procedure.
干预措施: EnligHTN™ Renal Denervation System. (Device)
Control Group
No Intervention
Subjects not receiving renal denervation procedure.
Subjects are randomized in a 3:1 ratio to either Renal Denervation Group or Control Group.
结局指标
主要结局
Change in insulin resistance from baseline to 3 months after renal denervation
时间窗: Baseline and Month 3
To determine the effects of renal sympathetic denervation on insulin resistance (determined by the Homeostasis Model Assessment - Insulin Resistance method) at 3 months after renal denervation
Change in muscle sympathetic nerve activity (MSNA) from baseline to 3 months after renal denervation
时间窗: Baseline and Month 3
To determine the effects of renal sympathetic denervation on MSNA at 3 months after renal denervation
次要结局
- Change in insulin resistance from baseline to 12 months after renal denervation(Baseline and Month 12)
- Change in muscle sympathetic nerve activity (MSNA) from baseline to 12 months after renal denervation(Baseline and Month 12)
研究者
研究点 (1)
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