EUCTR2018-004653-24-DK进行中（未招募）1 期
Impact of an Angiotensin Receptor Blocker in Aortic Stenosis – A Randomized Controlled Trial - ARBAS
Odense Universitets Hospital0 个研究点目标入组 280 人开始时间: 2019年12月4日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 280
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patients with mild-moderate AS (peak aortic jet velocity =2.5 and <4m/s)
- •2. Age >20 years = 85 years
- •3.LV ejection fraction =50%
- •4.Systolic blood pressure =1 00 mmHg
- •5.Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •1. More than mild aortic or mitral regurgitation or mitral stenosis
- •2. Current use of renin-angiotensin system medication (ACE-I, ARB or
- •direct renin inhibitor) in patients with arterial hypertension and diabetes
- •mellitus or arterial hypertension and chronic kidney disease stage 4-5
- •(estimated glomerular filtration rate <30ml/min/1.73m2)
- •3. Known allergy or intolerance to ARBs, poorly controlled blood
- •4. Renal dysfunction (estimated glomerular filtration
- •rate <30ml/min/1.73m2), chronic hyperkalemia (P-potassium >5.5
- •5. Hepatic failure, cirrhosis, hepatitis or history of hepatic impairment
- •6. Newly diagnosed (<2 months) or poorly controlled diabetes
- •7. Pre-existing obstructive coronary artery disease with CCS III-IV
- •angina or recent myocardial infarction (<3 months)
- •8. Pregnant or lactating women. Fertile women without highly effective
- •birth control method. Patients unable to read, understand or sign
- •research consent
研究者
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