Renal Sympathectomy in Treatment Resistant Essential Hypertension, a Sham Controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement
研究概览
简要总结
The purpose of this double blind, randomized and sham controlled study is to determine whether renal denervation in terms of catheter based ablation in the renal arteries is effective in lowering blood pressure in patients with treatment resistant hypertension. The blood pressure lowering effect will be evaluated by 24 hours ambulatory blood pressure measurement at baseline and after 1, 3 and 6 months of follow up. Secondary end point evaluation concerns hemodynamic measures using echocardiography, applanation tonometry and forearm plethysmography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systolic daytime ambulatory BP at least 145 mmHg and compliance to a minimum of 3 antihypertensive drugs, including a diuretic, or in case of diuretic intolerance at least 3 nondiuretic antihypertensive drugs.
排除标准
- •Pregnancy
- •Non compliance
- •Heart Failure (NYHA 3-4)
- •LV ejection fraction < 50 %
- •Renal insufficiency (eGFR<30)
- •Unstable coronary heart disease
- •Coronary intervention within 6 months
- •Myocardial infarction within 6 months
- •Claudication
- •Orthostatic syncope within 6 months
- •Secondary Hypertension
- •Permanent atrial fibrillation
- •Significant Heart Valve Disease
- •Clinically Significant abnormal electrolytes, haemoglobin, Liver enzymes, TSH
- •Second and third degree heart block
- •Macroscopic haematuria
- •Proximal significant coronary stenosis
- •Renal artery anatomy not suitable for renal artery ablation (Stenosis, small diameter < 4 mm, length < 2 cm, multiple renal arteries, severe calcifications)
研究组 & 干预措施
Renal artery ablation
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to active treatment, renal artery ablation will be carried out straight away.
干预措施: Renal artery ablation (Procedure)
Sham
By femoral access, coronary and renal angiography are performed. The patient will be sedated. In case of vessel anatomy allowing renal ablation, the patient will be randomized in the card. lab. In case of randomization to sham procedure, no renal artery ablation are performed.
干预措施: Renal angiography (Procedure)
结局指标
主要结局
daytime systolic blood pressure assessed by 24 hours ambulatory BP measurement
时间窗: 3 months follow up
Changes in mean daytime systolic BP after 3 months is compared between groups. Also the proportion of responders versus nonresponders after 3 months is compared between groups, responders being defined as A) a minimum decrease in daytime systolic BP of 10 mmHg analysis together with and unchanged/increased number of antihypertensive drugs, or B) a decrease in daytime systolic BP of 0-10 mmHg together with a reduced number of antihypertensive drugs.
次要结局
- Biomarkers(1 months)
- ambulatory 24 hours BP measurements(1, 3 and 6 months)
- Echocardiography(6 months)
- Applanation tonometry(6 months)
- forearm plethysmography(6 months)
研究者
Ole Norling Mathiassen
Dr.med
Aarhus University Hospital Skejby