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-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: S Jeson Sangaralingham, John C Burnett Jr, Paul M McKie, John A Schirger, Horng H Chen
• Journal: Journal of cardiac failure (J Card Fail) Vol. 19 Issue 8 Pg. 533-9 (Aug 2013) ISSN: 1532-8414 [Electronic] United States
• PMID: 23910581 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Natriuretic Peptide, Brain

Topics

• Double-Blind Method
• Humans
• Infusions, Intravenous
• Myocardial Infarction (drug therapy, epidemiology)
• Natriuretic Peptide, Brain (administration & dosage)
• Pilot Projects
• Sample Size
• Treatment Outcome
• Ventricular Function, Left (drug effects, physiology)