Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension
研究概览
详细说明
This will be a single centre, single arm, prospective cohort study. Patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. The study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies.
Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria associated with the procedure through 90 days. Efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Shanghai
-
Shanghai、Shanghai、中国、200092
- Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months.
Exclusion Criteria:
GFR < 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months.
Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis >50% or renal artery aneurysm in either renal artery. Others.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：stereotactic body radiotherapy (SBRT)
Noninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.
|
Image-guided stereotactic body radiation therapy
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety Endpoint
大体时间：90 days
|
Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria that are related to the procedure.
|
90 days
|
|
Ambulatory Blood Pressure Reduction
大体时间：90 days
|
Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment
|
90 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Office Blood Pressure Reduction
大体时间：90 days
|
Mean reduction in office blood pressure at 90 days post-treatment
|
90 days
|
|
Number of Drug Adjustments
大体时间：90 days
|
Number of drug adjustments for hypertension through 90 days after treatment
|
90 days
|
合作者和调查者
调查人员
- 首席研究员：Yi-Gang Li, MD、Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.