The impact of dose of the angiotensin-receptor blocker valsartan on the post-myocardial
infarction ventricular remodeling: study protocol for a randomized controlled trial
- Author(s)
- Young-Rak Cho; Young-Dae Kim; Tae-Ho Park; Kyungil Park; Jong-Sung Park; Heekyung Baek; Sun-Young Choi; Kee-Sik Kim; Taek-Jong Hong; Tae-Hyun Yang; Jin-Yong Hwang; Jong-Seon Park; Seung-Ho Hur; Sang-Gon Lee
- Keimyung Author(s)
- Hur, Seung Ho
- Department
- Dept. of Internal Medicine (내과학)
- Journal Title
- Trials
- Issued Date
- 2011
- Volume
- 12
- Issue
- 1
- Keyword
- Valsartan; Myocardial Infarction
- Abstract
- Background: Angiotensin-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/Design: Valsartan 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.
Discussion: VALID 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 registration: NCT01340326
Keywords: Valsartan, Myocardial Infarction
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