Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4 (HTN-4)
2017年4月24日 更新者：Medtronic Vascular
Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
An international, multi-center, prospective, blinded, randomized, controlled trial.
The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
研究概览
地位
完全的
详细说明
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure.
However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
研究类型
介入性
注册 (实际的)
44
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。
学习地点
-
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Georgia
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Atlanta、Georgia、美国、30309
- Piedmont Hospital
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North Carolina
-
Durham、North Carolina、美国、27710
- Duke University Medical Center
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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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 80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 on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
- Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
- Individual has ABPM average SBP greater than or equal to 135 mmHg
Exclusion Criteria:
- Individual lacks appropriate renal artery anatomy
- Individual has eGFR of less than 30
- Individual has Type I diabetes mellitus
- Individual has had one or more episodes of orthostatic hypotension
- Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
- Individual has primary pulmonary hypertension
- Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
- Individual is pregnant, nursing or planning to be pregnant
- Individual has had a previous organ transplant
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 |
|---|---|
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实验性的：Renal Denervation
Subjects are treated with the renal denervation procedure after randomization.
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Subjects randomized to the renal denervation group underwent angiography and renal denervation.
Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy.
Only subjects with eligible renal artery anatomy were randomized.
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其他：Control
Subjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only).
Once enrollment was closed and the protocol revised, no control subjects crossed-over.
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Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy.
Only subjects with eligible renal artery anatomy were randomized.
Prior to enrollment closure, subjects were treated with sham renal denervation.
After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Reaching BP Goal
大体时间：6 months post-randomization
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6 months post-randomization
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Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
大体时间：Baseline to 6 months
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Baseline to 6 months
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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。
调查人员
- 首席研究员：Michael Weber, MD、SUNY Downstate College of Medicine
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
2013年10月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2017年1月1日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月24日
首次发布 (估计)
2013年10月30日
研究记录更新
最后更新发布 (实际的)
2017年4月26日
上次提交的符合 QC 标准的更新
2017年4月24日
最后验证
2017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.