NCT01887067终止不适用
Renal Denervation Therapy for Resistant Hypertension in Type 2 Diabetes Mellitus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in office systolic & diastolic blood pressure from baseline to 6 months
研究概览
简要总结
To demonstrate the efficacy of renal denervation therapy in treating resistant hypertension and its effect on glucose metabolism in patients with type 2 diabetes mellitus
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Age ranges from 18 to 70 years inclusive
- •Essential hypertension
- •Office Systolic BP (SBP) ≥ 150 mmHg or Diastolic BP (DBP) ≥ 90mmHg
- •3 or more anti-hypertensive medications of different classes, including a diuretic, or documented intolerance to multiple medications
- •Type 2 Diabetes Mellitus on oral hypoglycaemic agent (OHA)
- •2 functional kidneys; eGFR ≥ 45 mL/min/1.73m² (MDRD formula)
- •Suitable renal anatomy compatible with the endovascular denervation procedure
排除标准
- •Individual has renal artery anatomy that is ineligible for treatment including:
- •Patients with secondary hypertension
- •Myocardial infarction, unstable angina pectoris, cerebrovascular accident within 6 months
- •Patient with type 1 diabetes mellitus
- •Patient on insulin due to oral drug failure
- •Renovascular abnormalities (including severe renal artery stenosis, previous renal stenting or angioplasty, or known dual renal arteries)
- •Pregnancy
- •Patient with any implantable device incompatible with radiofrequency energy delivery
- •Hemodynamically significant valvular heart disease for which reduction of BP would be considered hazardous
- •Any serious medical condition, which in the opinion of the investigator, may limit the life expectancy of patients or adversely
结局指标
主要结局
Change in office systolic & diastolic blood pressure from baseline to 6 months
时间窗: 6 months
次要结局
- Change in office systolic and diastolic blood pressure up to 3 years(3 years)
- Change in insulin sensitivity(12 months)
- Change in glucose metabolism(3 years)
研究者
Kin Lam TSUI
Consultant Physician
Pamela Youde Nethersole Eastern Hospital
研究点 (1)
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