A Clinical Study of the Ultrasound Renal Denervation System in Patients With Resistant Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 53
- 主要终点
- a decrease of average 24-hr ambulatory systolic BP from the baseline
研究概览
简要总结
The REQUIRE STUDY is a multi-center, randomized, double-blind, sham-controlled study, which aims to confirm the efficacy and safety of PRDS-001 (ReCor Medical Inc. Paradise in Europe) for renal denervation therapy in patients with treatment resistance hypertension, in comparison with the sham procedure.
详细描述
Patients with treatment resistance hypertension is defined patients being treated on 3 or more different classes of antihypertensive medications including diuretics.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •average office systolic BP of 150 mmHg or greater or office diastolic BP of 90 mmHg or greater (both in the sitting position)
- •24-hr ambulatory BP 140 mmHg or greater.
排除标准
- •Secondary hypertension (sleep apnoea can be included.)
- •Type I diabetes or uncontrolled Type II diabetes with HbA1c 8.4% or greater
- •Known or concurrent chronic active inflammatory bowel diseases (e.g. Crohn's disease, ulcerative colitis etc.)
- •eGFR<40 mL/min/1.73m2 (per predictive equation Japanese Society of Nephrology)
- •Known severe cardiovascular events within 3 months or severe cerebrovascular events
- •Patients those who are planned to receive PCI or other operation for iscaemic cardiovascular disease within 8 months
- •Concurrent persistent atrial fibrillation
- •Patients those who are on active implantable medical devices
- •Primary pulmonary hypertension
- •Patients those who are contraindicated to, or confirmed to have intolerable anaphylactic reaction or uncontrollable allergy to contrast media
研究组 & 干预措施
PRDS-001 Renal Denervation Ultrasound System
Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using PRDS-001 System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
干预措施: PRDS-001 Renal Denervation Ultrasound System (Device)
Sham Procedure
Randomization will occur following the diagnostic renal angiography. For blinded patients randomized to control, the diagnostic renal angiography will be considered the sham procedure.
干预措施: Sham Procedure (Procedure)
结局指标
主要结局
a decrease of average 24-hr ambulatory systolic BP from the baseline
时间窗: 3 month follow-up visit
次要结局
- a decrease of the average office BP (both systolic and diastolic) in the sitting position from the baseline(3 month follow-up visit)
- a decrease of the average ambulatory systolic BP during the daytime and that during the nighttime, from the baseline, respectively(3 month follow-up visit)
- a decrease of the average ambulatory diastolic BP during the daytime, and that during the nighttime, from the baseline, respectively(3 month follow-up visit)