HFS-guided Renal Ablation for Improving Outcome of Renal Denervation Procedure
High Frequency Guided Renal Artery Denervation for Improving Outcome of Renal Ablation Procedure
研究概览
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
-
Krasnoyarsk、俄罗斯联邦
- Federal Center of Cardiovascular surgery
-
Krasnoyarsk、俄罗斯联邦
- Regional Hospital
-
Moscow、俄罗斯联邦
- Federal Center of Prophylactic Medicine
-
-
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:
- Office-based systolic blood pressure of ≥140/90 mm Hg and <160/100 mm Hg (moderate resistant hypertension) or ≥160/100 mm Hg (severe resistant hypertension), despite treatment with 3 antihypertensive drugs (including a diuretic).
- A glomerular filtration rate ≥45 mL/min/1⋅73 m2, with modification of diet using a renal disease formula.
Exclusion Criteria:
- Secondary causes of hypertension
- Severe renal artery stenosis or dual renal arteries
- Congestive heart failure
- Left ventricular ejection fraction <35%
- Previous renal artery stenting or angioplasty
- Type 1 diabetes mellitus
学习计划
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group 1 (RDN guided by HFS)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. After that high-frequency stimulation (HFS) was used before the initial and after each radiofrequency (RF) delivery within the renal artery. RDN was considered to have been achieved when the sudden increase of blood pressure (> 15 mm Hg from invasive arterial monitoring) was eliminated in response to HFS. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. |
|
|
有源比较器：Group 2 (RDN as standard procedure)
Renal arteries were assessed for suitability of ablation by renal angiography. The real-time 3-dimensional aorta-renal artery maps were reconstructed with the use of navigation system and ablation catheter via femoral artery access. RF ablations of 8-12 watts (impedance drop >10%) were applied discretely from the first distal main renal artery bifurcation all the way back to the ostium. The duration of each RF delivery was 60-120 sec, and up to 6 lesions (separated by > 5 mm) were performed both longitudinally and rotationally within each renal artery. High-frequency stimulation (HFS) was performed before and after RDN to just to verify the response of BP |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
number of responders to renal denervation procedure
大体时间：12 month
|
12 month
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
complications rate
大体时间：12 month
|
12 month
|
|
cross-over rate
大体时间：12 month
|
12 month
|
合作者和调查者
研究记录日期
研究主要日期
学习开始
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 (估计)
研究记录更新
最后更新发布 (估计)
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.