title: Rationale and design of a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of B-type natriuretic peptide for the preservation of left ventricular function after anterior myocardial infarction.
abstract: BACKGROUND
  B-type natriuretic peptide (BNP) is a hormone with pleiotropic cardioprotective properties. Previously in our non-placebo-controlled non-blinded pilot study (BELIEVE) in human ST-segment-elevation anterior acute myocardial infarction (AMI), a 72-hour intravenous (IV) infusion of recombinant human BNP (nesiritide) at a dose of 0.006 μg kg(-1) min(-1) suppressed plasma aldosterone, reduced cardiac dilatation, and improved left ventricular (LV) ejection fraction (LVEF) at 1 month compared with baseline.
  
  
  METHODS
  The BELIEVE II study is a phase II, randomized, double-blind, placebo-controlled, single-center clinical trial to assess the efficacy of 72-hour IV infusion of nesiritide therapy (0.006 μg kg(-1) min(-1)) in humans with first-time ST-segment-elevation anterior AMI and successful reperfusion, in preventing adverse LV remodeling and preserving LV function. A total of 60 patients will be randomized to placebo or nesiritide therapy. The primary efficacy end point is LV end-systolic and end-diastolic dimensions determined by multiple gated acquisition scan between placebo and nesiritide groups at 30 days; secondary end points include 30-day LVEF, diastolic function, infarct size, LV mass, and combined total mortality and heart failure hospitalization.
  
  
  CONCLUSIONS
  This will be the first randomized, double-blind, placebo-controlled clinical trial to assess the clinical efficacy of nesiritide in human ST-segment-elevation anterior AMI.
authors.affiliation: Cardiorenal Research Laboratory, Division of Cardiovascular Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA.
authors.forename: S Jeson
authors.initials: SJ
authors.lastname: Sangaralingham
authors.forename: John C
authors.initials: JC
authors.lastname: Burnett
authors.forename: Paul M
authors.initials: PM
authors.lastname: McKie
authors.forename: John A
authors.initials: JA
authors.lastname: Schirger
authors.forename: Horng H
authors.initials: HH
authors.lastname: Chen
mesh_terms: D004311:Double-Blind Method; D006801:Humans; D007262:Infusions, Intravenous; D009203:Myocardial Infarction / Q000188:drug therapy* / Q000453:epidemiology; D020097:Natriuretic Peptide, Brain / Q000008:administration & dosage*; D010865:Pilot Projects; D018401:Sample Size; D016896:Treatment Outcome; D016277:Ventricular Function, Left / Q000187:drug effects* / Q000502:physiology
chemical_list: D020097:Natriuretic Peptide, Brain
keywords: Nesiritide; coronary artery disease; protein therapeutics
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