NCT02444442已完成不适用
The Australian SHAM Controlled Clinical Trial of Renal DeNervation in Patients With Resistant Hypertension (AUSHAM-RDN-01)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Change in ambulatory systolic blood pressure between groups
研究概览
简要总结
The purpose of this study is to assess the efficacy of catheter-based renal denervation in reducing blood pressure in patients with resistant hypertension compared to a sham procedure. Patients will be randomized to RDN or sham control in a 2:1 ratio. All participants will be switched to a single pill triple combination treatment prior to the procedure.
A total of 105 patients will be recruited into the study, 70 patients in the RDN arm and 35 patients in the sham control arm.
The duration of this study is 36 months.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systolic office BP ≥140mmHg and ambulatory day time average ≥135mmHg despite concurrent treatment with ≥3 anti-hypertensive drugs
排除标准
- •renal artery anatomy ineligible for treatment
- •eGFR <15mL/min/1.73m2 (using MDRD calculation)
- •myocardial infarction, unstable angina or cerebrovascular accident within 3 months of screening visit
- •life expectancy of <12 months
- •female participants of childbearing potential must have negative pregnancy test prior to treatment
结局指标
主要结局
Change in ambulatory systolic blood pressure between groups
时间窗: 6 months post procedure
Difference in mean ambulatory systolic daytime blood pressure between RDN group and sham-control group at 6 month follow up.
次要结局
- Change in mean 24h systolic blood pressure between groups(6 months post procedure)
- Change in mean night time systolic blood pressure between groups(6 months post procedure)
- Change in mean office systolic blood pressure between groups(6 months post procedure)
研究者
研究点 (2)
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