The Clinical Efficacy Comparison of Two Renal Sympathetic Denervation Strategies ---- Full Length Versus Proximal Renal Arteries Ablation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
Catheter-based renal sympathetic modification has been documented to be effective option for blood pressure control in patients with resistant hypertension, but the safety is still concerned around worldwide. Based on anatomic findings, blocking renal sympathetic nerves at proximity may be enough for successful renal sympathetic modifications. This study was designed to compare the efficacy and safety of full length versus proximal ablation of bilateral renal arteries.
详细描述
After baseline assessment was completed, patients with resistant hypertension were enrolled, and randomly divided into two groups. This study is going to recruit 40 patients (group 1 VS group 2 = 1:1) with a follow-up duration of one year. Group 1 received ablation from distal to ostial of bilateral renal arteries, group 2 received ablation at proximal of bilateral renal arteries. RDN was performed with saline irrigated catheter. Office and ambulatory blood pressure was measured.
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
- 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
- •office systolic blood pressure of 160 mm Hg or more,
- •patients had to be on a stable drug regimen of at least 3 antihypertensive medications with no changes for 1 month before enrollment.
- •Despite being treated with at least three antihypertensive drugs(including one diuretic), or confirmed intolerance to medications;
- •≥ 18 years old,;
- •did not have any known secondary cause of hypertension;
- •had a glomerular filtration rate estimated with the modification of diet in renal disease formula, of 45 ml/min/1.73m2 or more.
排除标准
- •patients with type 1 diabetes,
- •implanted pacemakers or implantable cardioverter defibrillators;
- •pregnant women;
- •haemodynamically significant valvular disease;
- •patients with renovascular abnormalities(including mild to severe renal artery stenosis, especially caused by atherosclerosis, previous renal stenting or angioplasty, or known dual renal arteries, or diameter of renal artery identified by angiography less than 4 mm and/or length of renal artery less than 2 cm)
研究组 & 干预措施
Group 1
Group 1 received ablation from distal to ostial of bilateral renal arteries
干预措施: Thermocool®Rcatheter (Device)
Group 2
group 2 received ablation at proximal of bilateral renal arteries
干预措施: Thermocool®Rcatheter (Device)
结局指标
主要结局
Blood pressure
时间窗: one year
office BP and Ambulatory blood pressure
次要结局
- ablation-related complications(one year)
研究者
Yuehui Yin
Director and Professor, Dept. of Cardiology, the second affiliated hospital of Chongqing Medical University, Chongqing Cardiac arrhythmias service center
The Second Affiliated Hospital of Chongqing Medical University