2024-517342-33-01进行中（未招募）2 期
IcoSApent ethyL to slow down aortic VAlve stenosis proGrEssion (SALVAGE)
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in aortic valve calcium (AVC) score
研究概览
简要总结
To study the effect of icosapent ethyl on progression of aortic valve calcification.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years
- •Mild to moderate aortic valve stenosis
排除标准
- •Bicuspid aortic valve
- •History of chest radiotherapy
- •History of rheumatic fever
- •Moderate to severe renal failure, defined as eGFR < 30 ml/min
结局指标
主要结局
Change in aortic valve calcium (AVC) score
时间窗: 2 years
continuous variable
次要结局
- Change in peak aortic jet velocity at 24 months
- Change in calculated aortic valve area (AVA) at 24 months
- Total coronary plaque volume progression (mm2)
- Non-calcified coronary plaque volume progression (mm2)
研究者
Matthijs Boekholdt
Principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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