title: The impact of dose of the angiotensin-receptor blocker valsartan on the post-myocardial infarction ventricular remodeling: study protocol for a randomized controlled trial.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT01340326.
authors: Department of Internal Medicine, Dong-A University College of Medicine, Busan, Korea.
authors: Young-Rak
authors: YR
authors: Cho
authors: Young-Dae
authors: YD
authors: Kim
authors: Tae-Ho
authors: TH
authors: Park
authors: Kyungil
authors: K
authors: Park
authors: Jong-Sung
authors: JS
authors: Park
authors: Heekyung
authors: H
authors: Baek
authors: Sun-Young
authors: SY
authors: Choi
authors: Kee-Sik
authors: KS
authors: Kim
authors: Taek-Jong
authors: TJ
authors: Hong
authors: Tae-Hyun
authors: TH
authors: Yang
authors: Jin-Yong
authors: JY
authors: Hwang
authors: Jong-Seon
authors: JS
authors: Park
authors: Seung-Ho
authors: SH
authors: Hur
authors: Sang-Gon
authors: SG
authors: Lee
mesh_terms: D000328:Adult; D000368:Aged; D057912:Angiotensin II Type 2 Receptor Blockers / Q000627:therapeutic use*; D002985:Clinical Protocols; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000503:physiopathology*; D011446:Prospective Studies; D018401:Sample Size; D016037:Single-Blind Method; D013777:Tetrazoles / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D014633:Valine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D000068756:Valsartan; D018487:Ventricular Dysfunction, Left / Q000188:drug therapy*; D020257:Ventricular Remodeling / Q000187:drug effects*
chemical_list: D057912:Angiotensin II Type 2 Receptor Blockers; D013777:Tetrazoles; D000068756:Valsartan; D014633:Valine