Global Left Ventricular Function After Acute Myocardial Infarction. Treatment With the Angiotensin 2-Receptor Blocker Irbesartan
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Left ventricular function
研究概览
简要总结
The purpose of this study is to compare changes in global left ventricular (LV) function after 3 months of treatment with irbesartan compared with usual care in patients with acute myocardial infarction, a wall motion score >1.3 (EF>0.40) and signs of diastolic dysfunction. The hypothesis is that an angiotensin 2-receptor inhibitor will improve global left ventricular function.
详细描述
Study objectives:
Primary Objective:
To compare the change in global LV function assessed with myocardial performance index (MPI) after 3 months treatment with irbesartan compared to usual care in patients admitted to hospital with acute myocardial infarction, wall motion score index > 1.3 (LVEF > 0.40), and MPI > 0.55.
Secondary Objectives:
- To compare irbesartan added to an ACE-inhibitor compared to usual care in patients with AMI, WMSI <= 1.3 and MPI > 0.55;
- To compare LV diastolic function assessed by pulse wave and color M-mode Doppler echocardiography and left atrial size after treatment with irbesartan compared to usual care in AMI and
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented AMI; MPI > 0.55
- •Randomized within 7 days of AMI
- •Written informed consent
排除标准
- •Age < 18 years
- •Any contraindications to angiotensin 2-receptor blockade
- •In patients with WMSI > 1.3 treatment with ACE-inhibitor or angiotensin 2-receptor blockers
- •In patients with WMSI <= 1.3 no initiated or planned treatment with an ACE-inhibitor. Treatment with an ACE-inhibitor must be started within 7 days
- •Pregnancy or women of childbearing potential who are not using an effective method of contraception
- •Other comorbid conditions that could influence the study
- •Currently receiving an experimental study drug
研究组 & 干预措施
Irbesartan
Tablet Irbesartan 150 mg once daily
干预措施: Irbesartan Oral Tablet (Drug)
结局指标
主要结局
Left ventricular function
时间窗: 3 months
次要结局
未报告次要终点
研究者
Kenneth Egstrup
Professor
University of Southern Denmark