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Abstract
BackgroundAngiotensin-converting enzyme inhibitors and the angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). Based on previous clinical trials, a maximum clinical dose is recommended in practical guidelines. Yet, has not been clearly demonstrated whether the recommended dose is more efficacious compared to the lower dose that is commonly used in clinical practice.Method/DesignValsartan in post-MI remodeling (VALID) is a randomized, open-label, single-blinded multicenter study designed to compare the efficacy of different clinical dose of valsartan on the post-MI ventricular remodeling. This study also aims to assess neurohormone change and clinical parameters of patients during the post-infarct period. A total of 1116 patients with left ventricular dysfunction following the first episode of acute ST-elevation MI are to be enrolled and randomized to a 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 is to be conducted in central core laboratory. Clinical assessment and laboratory test are performed at fixed times.DiscussionVALID is a multicenter collaborative study to evaluate the impact of dose of valsartan on the post-MI ventricular remodeling. The results of the study provide information about optimal dosing of the drug in the management of patients after MI. The results will be available by 2012.Trial registrationNCT01340326
Highlights
Angiotensin-converting enzyme inhibitors and the angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI)
Based on the results from major pivotal clinical trials, it is usually recommended in practical guidelines that the maximal clinical dose of angiotensin-converting enzyme (ACE) inhibitors used in those trials be given to patients after acute MI [13,14]
In the VALIANT study [17], addition of ARB valsartan to ACE inhibitor resulted in similar degree of post-MI left ventricular (LV) remodeling compared to either drug alone, in the Val-HeFT study [18], LV remodeling in heart failure was more favorable in the combination therapy group
Summary
Angiotensin-converting enzyme inhibitors and the angiotensin-receptor blocker valsartan ameliorate ventricular remodeling after myocardial infarction (MI). In the VALIANT study [17], addition of ARB valsartan to ACE inhibitor resulted in similar degree of post-MI left ventricular (LV) remodeling compared to either drug alone, in the Val-HeFT study [18], LV remodeling in heart failure was more favorable in the combination therapy group. The question of whether submaximal dose of ARB, which are lower than those in major pivotal trials but typically used in clinical practice, can offer similar benefit in post-MI ventricular remodeling remains to be solved. This is more so in the Asian population, wherein moderate dose ARB has been shown to provide sufficient protection from cardiovascular risk [23]. The comparison dose of valsartan will be 80 mg per day, as commonly prescribed after MI in Korea, versus 320 mg per day, a targeted dose in major clinical trials [12,24]
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