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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
800
comparison of different dosages of drug
comparison of different dosages of drug
Department of Internal Medicine,Dong-A University College of Medicine
Busan, South Korea
Change in the left ventricular volume index from baseline to follow-up
We measured a left ventriular volume index by echocardiography.
Time frame: at 24hrs, 1month, and 12months after myocardial infarction
left ventricular volume index
Time frame: at 12months after myocardial infarction
clinical events
Clinical events were defined as all cause death and hospitalization due to cardiovascular problems.
Time frame: during 12 months follow up
clinical events
Time frame: at 12 months after myocardial infarction
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