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 and design

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-elevati

SUBMITTER: Sangaralingham SJ 

PROVIDER: S-EPMC3869096 | biostudies-literature | 2013 Aug

REPOSITORIES: biostudies-literature