The Impact of Dose of Angiotensin-receptor Blocker Valsartan and Genetic Polymorphism on the Post-MI Ventricular Remodeling
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Change in the left ventricular volume index from baseline to follow-up
研究概览
简要总结
Angiotensin-converting enzyme inhibitors and angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Although the amount of those drugs used in previous clinical trials, therefore recommended in practical guidelines is maximum clinical dose, it has not been clearly demonstrated whether the recommended dose is more efficacious compared to lower dose commonly used in clinical practice. In addition, the impact of genetic polymorphism in neurohormonal system on the pharmacological effect has not been explored in the setting of post-MI remodeling.
Therefore, the investigators evaluate whether submaximal dose, which are lower than those in major pivotal trials but typically used in clinical practice, can offer similar benefit in post-MI ventricular remodeling.
详细描述
A total of 1116 patients with left ventricular (LV) dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to maximal tolerable dose (up to 320 mg/day) or usual dose (80 mg/day) of valsartan for 12 months in 2:1 ratio. Echocardiographic analysis for quantifying post-MI ventricular remodeling and genotyping of blood samples are conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times, and genetic polymorphisms of the patients are tested at the time of admission.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both gender
- •Age > 18
- •First episode of acute ST-elevation MI
- •An echocardiographic left ventricular ejection fraction less than 50 %
- •Patients who provide written informed consent
排除标准
- •Contraindications for use of angiotensin receptor blockers (ARBs)(hypersensitivity, pregnancy, bilateral renal artery stenosis)
- •Urgent need for revascularization procedure
- •Severe heart failure (need for intravenous inotropic support)
- •Persistent (> 1 hour) severe hypotension (systolic blood pressure < 90 mmHg)
- •Refractory or potentially lethal arrhythmias
- •Hemodynamically significant right ventricular infarction
- •Primary valvular diseases
- •Congenital heart disease
- •Idiopathic hypertrophic cardiomyopathy
- •Concomitant inflammatory cardiopathy
- •Significant hepatic dysfunction
- •Significant renal dysfunction
- •Anemia (hemoglobin < 10 mg/mL)
- •Psychiatric disorders, alcohol or durg abuse
- •Any concomitant disease that might interfere with drug evaluation (especially if life expectancy is less than 1 year)
- •Participation in any other pharmacological study within 2 months
- •Refusal or inability to provide informed consent
研究组 & 干预措施
Valsartan, usual dose
usual dose group (valsartan 80 mg/day)
干预措施: usual dose of valsartan (Drug)
Valsartan,high dose
high dose group (valsartan up to 320 mg/day)
干预措施: high dose of valsartan (Drug)
结局指标
主要结局
Change in the left ventricular volume index from baseline to follow-up
时间窗: at 24hrs, 1month, and 12months after myocardial infarction
We measured a left ventriular volume index by echocardiography.
left ventricular volume index
时间窗: at 12months after myocardial infarction
次要结局
- clinical events(at 12 months after myocardial infarction)
研究者
Kyungil Park
Assistant professor
Dong-A University