Renal Denervation With Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
2018年4月26日 更新者:Synaptic Medical Limited
A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
研究概览
研究类型
介入性
注册 (预期的)
264
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Jiayi Wang
- 电话号码:+86-18511291205
- 邮箱:jiayi.wang@synapticmed.com.cn
研究联系人备份
- 姓名:Qing Liu
- 电话号码:+86-18701241121
- 邮箱:qing.liu@synapticmed.com.cn
学习地点
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Beijing
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Beijing、Beijing、中国、100034
- 招聘中
- Peking University First Hospital
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接触:
- Hanhua Wang
- 电话号码:+86-010-66119205
- 邮箱:jgbgs090101@126.com
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副研究员:
- WEI Ma, MD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Individual is ≥18 years and ≤65 years old.
- Primary hypertension.
- Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and <170mmHg at the fourth week after screening.
Exclusion Criteria:
- Secondary hypertension.
- History of prior renal artery intervention including balloon angioplasty or stenting.
- Renal artery stenosis (≥50%) in either renal artery.
- Main renal arteries with <4mm, or >8mm in diameter.
- Main renal arteries with <20mm in length.
- Estimated glomerular filtration rate (eGFR) of <40 ml/(min•1.73m2).
- History of Stroke or TIA within 6 months prior to screening period.
- History of Acute coronary syndrome within 6 months prior to screening period.
- Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
- Heart failure (NYHA classification Ⅲ-Ⅳ).
- Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
- History of cancer.
- Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
- Acute or severe systemic inflammatory response syndrome.
- Any other serious medical condition unqualified to participate in this study evaluated by investigator.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Renal denervation
Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications
|
After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.
其他名称:
A renal angiography according to standard procedure.
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假比较器:Renal angiography
Renal angiography and maintaining anti-hypertensive medications
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A renal angiography according to standard procedure.
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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 |
---|---|---|
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
大体时间:from baseline to 3 months post-procedure
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Primary effective outcome measure
|
from baseline to 3 months post-procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in office systolic blood pressure
大体时间:from baseline to 3 months post-procedure
|
Secondary effective outcome measure
|
from baseline to 3 months post-procedure
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Classes of anti-hypertensive medicine taken by participants
大体时间:6 months post-procedure
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Secondary effective outcome measure
|
6 months post-procedure
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Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)
大体时间:from 3 months post-procedure to 6 months post-procedure
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Secondary effective outcome measure
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from 3 months post-procedure to 6 months post-procedure
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in serum creatinine
大体时间:from baseline to 3 months post-procedure and 6 months post-procedure
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Safety outcome assessment
|
from baseline to 3 months post-procedure and 6 months post-procedure
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Incidence of renal stenosis
大体时间:6 months post-procedure
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Safety outcome assessment
|
6 months post-procedure
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Other acute and chronic safety evaluating by the incidence of major adverse event
大体时间:6 months post-procedure
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Safety outcome assessment
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6 months post-procedure
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年4月11日
初级完成 (预期的)
2020年6月1日
研究完成 (预期的)
2020年9月1日
研究注册日期
首次提交
2018年3月26日
首先提交符合 QC 标准的
2018年4月26日
首次发布 (实际的)
2018年4月27日
研究记录更新
最后更新发布 (实际的)
2018年4月27日
上次提交的符合 QC 标准的更新
2018年4月26日
最后验证
2018年4月1日
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.
Renal denervation的临床试验
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Hippocration General HospitalReCor Medical, Inc.招聘中