Reintervention After Previous Renal Denervation in Non-responding Patients With Severe Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Office Blood pressure measurement
研究概览
简要总结
The purpose of this study is to determine the effect of repeated renal denervation in non-responding patients with severe hypertension. Therefore ultrasound technique will be used.
详细描述
Renal Denervation is a CE-certified opportunity for treating patients with therapy-refractory hypertension. In some patients it doesn't show a significant lowering of the blood pressure, so a repeated renal denervation is an option.
In this study repeated renal denervation will be performed with the Recor Paradise Ultrasound Catheter.
For the study no specific procedures are required which would exceed the standard renal denervation procedure with the CE-certified Recor Paradise Ultrasound Catheter System.
There are no additional risks for the patient in consequence of participating in the study or the follow up procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is ≥18 years old
- •Individual received renal denervation ≥12 months prior to study participation to no therapeutical avail and is scheduled for reintervention.
- •Systolic Office based blood pressure ≥140mmHg
- •Individual receives 3 or more antihypertensive drugs including one diuretic
- •Individual is willing to provide written informed consent to participate in this study
排除标准
- •Individual has hypertension secondary to an identifiable and treatable cause
- •Individual has any serious medical condition which in the opinion of the investigator may adversely affect the participation.
- •Individual is pregnant, nursing or planning to be pregnant
- •Renal artery abnormalities which may affect the procedure
结局指标
主要结局
Office Blood pressure measurement
时间窗: up to1 year
次要结局
未报告次要终点
研究者
Prof. Dr. Horst Sievert
M.D.
Cardiovascular Center Frankfurt