Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 6
- 主要终点
- Reaching BP Goal
研究概览
简要总结
An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.
详细描述
After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic
- •Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg
- •Individual has ABPM average SBP greater than or equal to 135 mmHg
排除标准
- •Individual lacks appropriate renal artery anatomy
- •Individual has eGFR of less than 30
- •Individual has Type I diabetes mellitus
- •Individual has had one or more episodes of orthostatic hypotension
- •Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea
- •Individual has primary pulmonary hypertension
- •Individual has other concomitant conditions that may adversely affect the patient or the study outcomes
- •Individual is pregnant, nursing or planning to be pregnant
- •Individual has had a previous organ transplant
结局指标
主要结局
Reaching BP Goal
时间窗: 6 months post-randomization
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)
时间窗: Baseline to 6 months
次要结局
未报告次要终点