NCT03511313Unknown不适用
A Prospective, Multi-centers, Randomized, Controlled Study of Assessing the Safety and Efficacy of Sterile Irrigated Deflectable Ablation Catheter Used in Renal Artery in Primary Hypertension
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of renal denervation with sterile irrigated deflectable ablation catheter used in renal artery in primary hypertension in China.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individual is ≥18 years and ≤65 years old.
- •Primary hypertension.
- •Screen criteria: Individual who received a stable anti-hypertensive medication regimen including 2 or more anti-hypertensive medications of different classes prior to screening, and at the initial screening visit, he has an office systolic blood pressure(SBP)≥ 150mmHg, and ≤180mmHg, is entering the screening period after writing the informed consent. Individual is receiving a 4week standard dose of amlodipine besylate (Norvasc) and Losartan Potassium and Hydrochlorothiazide tablets (HYZAAR®), and has a SBP≥150mmHg and<180mmHg at the second week after screening, and has an Ambulatory 24-hour daytime average systolic blood pressure monitoring ≥140mmHg and <170mmHg at the fourth week after screening.
排除标准
- •Secondary hypertension.
- •History of prior renal artery intervention including balloon angioplasty or stenting.
- •Renal artery stenosis (≥50%) in either renal artery.
- •Main renal arteries with <4mm, or >8mm in diameter.
- •Main renal arteries with <20mm in length.
- •Estimated glomerular filtration rate (eGFR) of <40 ml/(min•1.73m2).
- •History of Stroke or TIA within 6 months prior to screening period.
- •History of Acute coronary syndrome within 6 months prior to screening period.
- •Structural heart disease without receiving effective treatment; Coronary heart disease with β blockers; severe peripheral artery disease that affecting blood pressure measurement and other unqualified conditions evaluated by investigator.
- •Heart failure (NYHA classification Ⅲ-Ⅳ).
- •Coagulation disorders associated with significant bleeding tendency, and history of other blood system diseases.
- •History of cancer.
- •Type 1 diabetes mellitus; Type 2 diabetes mellitus with target organ injuring.
- •Acute or severe systemic inflammatory response syndrome.
- •Any other serious medical condition unqualified to participate in this study evaluated by investigator.
研究组 & 干预措施
Renal denervation
Experimental
Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications
干预措施: Renal denervation (Device)
Renal denervation
Experimental
Renal angiography and renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), and maintaining anti-hypertensive medications
干预措施: Renal angiography (Diagnostic Test)
Renal angiography
Sham Comparator
Renal angiography and maintaining anti-hypertensive medications
干预措施: Renal angiography (Diagnostic Test)
结局指标
主要结局
Change in daytime average systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring
时间窗: from baseline to 3 months post-procedure
Primary effective outcome measure
次要结局
- Change in office systolic blood pressure(from baseline to 3 months post-procedure)
- Incidence of achieving target office systolic blood pressure (office SBP<140mmHg)(from 3 months post-procedure to 6 months post-procedure)
- Classes of anti-hypertensive medicine taken by participants(6 months post-procedure)
研究者
研究点 (1)
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