NCT01874470终止3 期
Renal Denervation by Allegro System in Patients With Resistant Hypertension
Shanghai AngioCare Medical1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Change in office-based systolic blood pressure (SBP) from baseline to 6 months
研究概览
简要总结
The purpose of ALLEGRO-HTN trial is to evaluate the safety and effectiveness of renal denervation in subjects with resistant hypertension by using Allegro renal denervation system
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 65 years at time of randomization
- •Stable medication regimen including 3 or more antihypertensive medications of different classes, including a diuretic (with no changes for a minimum of 4 weeks prior to screening) and no expected changes for at least 6 months
- •Office SBP and/or DBP ≥160/100 mm Hg ( ≥ 150/95 mmHg for type II diabetic patients) , 2) ABPM 24 hour average SBP and/or DBP ≥140 and/or 90 mmHg
- •Main renal arteries with ≥4 mm diameter or with ≥20 mm treatable length (by visual estimation)
- •eGFR≥45 mL/min/1.73 m2
- •Written informed consent
排除标准
- •Type 1 diabetes mellitus
- •Secondary hypertension
- •Has an implantable cardioverter defibrillator (ICD) or pacemaker
- •Myocardial infarction, unstable angina pectoris, syncope, or a cerebrovascular accident within 6 months of the screening period
- •Intravascular thrombosis or unstable atherosclerotic plaques
- •Has hemodynamically significant valvular heart disease
- •Pregnant, nursing, or planning to be pregnant
- •Any serious medical condition that may adversely affect the safety of the participant or the study
- •Currently enrolled in another investigational drug or device trial
- •Angiographic Exclusion Criteria:
- •Renal artery stenosis (≥50%) or renal artery aneurysm in either renal artery
- •History of prior renal artery intervention including balloon angioplasty or stenting
- •Multiple renal arteries where the main renal artery is estimated to supply <75% of the kidney
- •Main renal arteries with <4 mm diameter or with <20 mm treatable length (by visual estimation)
- •Renal artery abnormalities
结局指标
主要结局
Change in office-based systolic blood pressure (SBP) from baseline to 6 months
时间窗: 6 month
次要结局
- Change in average 24-hour SBP by ambulatory blood pressure monitoring (ABPM) from baseline to 6 months(6 month)
- • The incidence of major adverse events (MAE) at 1 month postrandomization(1-month post randomization)
- Office SBP and DBP at 1, 3, 6 months postrandomization(up to 6 months)
- • Patient-recorded home systolic blood pressure at 1, 3, 6 months postrandomization(up to 6 months)
- • MAE at 6-month post-randomization, including new renal artery stenosis >60%(up to 6 months)
研究者
研究点 (1)
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