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

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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.

Original languageEnglish (US)
Pages (from-to)533-539
Number of pages7
JournalJournal of Cardiac Failure
Volume19
Issue number8
DOIs
StatePublished - Aug 2013

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Brain Natriuretic Peptide
Controlled Clinical Trials
Left Ventricular Function
Myocardial Infarction
Placebos
Intravenous Infusions
Ventricular Remodeling
Aldosterone
Stroke Volume
Reperfusion
Dilatation
Hospitalization
Heart Failure
Clinical Trials
Hormones
Mortality
Therapeutics

Keywords

  • coronary artery disease
  • Nesiritide
  • protein therapeutics

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{e3618eb848a24dd18c3c038a37556bc3,
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 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.",
keywords = "coronary artery disease, Nesiritide, protein therapeutics",
author = "Sangaralingham, {S Jeson} and Burnett, {John C Jr.} and Paul McKie and Schirger, {John A.} and Chen, {Horng Haur}",
year = "2013",
month = "8",
doi = "10.1016/j.cardfail.2013.06.002",
language = "English (US)",
volume = "19",
pages = "533--539",
journal = "Journal of Cardiac Failure",
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T1 - 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

AU - Sangaralingham, S Jeson

AU - Burnett, John C Jr.

AU - McKie, Paul

AU - Schirger, John A.

AU - Chen, Horng Haur

PY - 2013/8

Y1 - 2013/8

N2 - 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.

AB - 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.

KW - coronary artery disease

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KW - protein therapeutics

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