Evaluation of Arterial Stiffness as a Predictor of Response to Renal Sympathetic Denervation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
研究概览
简要总结
This trial is designed to establish invasive and non-invasive measures of arterial stiffness as potential predictors of treatment response to renal sympathetic denervation
详细描述
Regardless of the ongoing debate on the general effect of renal sympathetic denervation in therapy resistant hypertension, all trials published so far face the problem of a certain proportion of nonresponders to treatment. Previous data shows, that to some extent this might be attributable to arterial stiffening. Elevated invasive pulse wave velocity as an established marker for arterial stiffness has been found to be associated with nonresponse to renal denervation treatment in a smaller trial population. This trial attempts to assess the predictive value of different invasive and non-invasive markers for arterial stiffness in an adequately powered population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with therapy resistant arterial hypertension (>=3 antihypertensive drugs including at least one diuretic without any dosage change in the preceding 4 weeks) and office BP >160 mmHg systolic or 90 mmHg diastolic
排除标准
- •average systolic daytime BP <135 mmHg in 24h ambulatory blood pressure measurement (ABPM)
- •pregnancy
- •known renal artery stenosis
- •>= 1 renal artery diameter < 4 mm
- •life expectancy <6 months
- •participation in any other clinical trial
结局指标
主要结局
Predictive value of invasive Pulse wave velocity for blood pressure response after renal denervation
时间窗: 3 Months
difference in daytime blood pressure (ABPM) between patients with low (\<14.4 m/s) vs. high invasive pulse wave velocity
Predictive value of noninvasive and invasive measures of arterial stiffness (Pulse wave velocity assessed invasively, with a piezoelectric device and MRI-based) in combination with clinical variables
时间窗: 3 Months
AUC of ROCs for noninvasive and invasive measures of arterial stiffness in predicting blood pressure response to renal denervation
次要结局
- Predictive value of MRI-assessed total arterial compliance on Change in daytime ambulatory blood pressure(3 months, 6 months, 12 months)
- Predictive value of MRI-assessed total arterial compliance on Change in 24 h ambulatory blood pressure(3 months, 6 months, 12 months)
- Change in 24h ambulatory blood pressure(3 months, 6 months, 12 months)
- Change in exercise blood pressure(3 months)
- comparison of predictive value of invasive pulse wave velocity, invasive central pulse pressure, noninvasive pulse wave velocity, noninvasive central pulse pressure, aortic distensibility, total arterial compliance for Change in ambulatory blood pressure(3 months, 6 months, 12 months)
- Predictive value of MRI-assessed aortic distensibility on Change in daytime ambulatory blood pressure(3 months, 6 months, 12 months)
- Predictive value of MRI-assessed aortic distensibility on Change in 24 h ambulatory blood pressure(3 months, 6 months, 12 months)
研究者
Philipp Lurz
Clinical Investigator, Professor, Managing Senior Physician
Heart Center Leipzig - University Hospital