Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2013-04-30

Brief Summary

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The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infarction left ventricular remodeling.

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Detailed Description

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Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences. Previous studies have demonstrated that LV remodeling is one of the major determinants of long-term survival post AMI. Recent studies have reported that the cardiac natriuretic peptides, atrial natriuretic peptide (ANP) and BNP have direct anti-fibrotic and anti-proliferative effects on the myocardium. More importantly, it has been reported that in the acute phase of AMI, the secretion of the cardiac natriuretic peptides may be insufficient relative to the chronic phase. Therefore, augmentation of the cardiac natriuretic peptide system, such as by exogenous administration of exogenous peptide may prevent post AMI LV remodeling because of the cardioprotective effects. The objective of this study is to to determine the efficacy of IV human BNP (Nesiritide) as compared to placebo to prevent adverse post AMI LV remodeling. This is a randomized double blinded placebo controlled study to determine efficacy of 72 hours of IV BNP at 0.006µg/Kg/min as compared to placebo in patients with anterior ST-elevation myocardial infarction and successful revascularization. The study population will include 60 patients admitted to the Cardiac Care Unit with a first anterior AMI and successful reperfusion therapy (TIMI grade 3 flow) within 24 hours of onset of chest pain documented by coronary angiography.

Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Infusion of 72 hours of saline solution (packaged to match active comparator).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion of 72 hours of saline solution (packaged to match active comparator)

Nesiritide

Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Group Type ACTIVE_COMPARATOR

Nesiritide

Intervention Type DRUG

Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Interventions

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Nesiritide

Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Intervention Type DRUG

Placebo

Infusion of 72 hours of saline solution (packaged to match active comparator)

Intervention Type DRUG

Other Intervention Names

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Natrecor BNP

Eligibility Criteria

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Inclusion Criteria

* Patients with acute ST elevation myocardial infarction with \> or = 2 mm ST elevation in one or any combination of anterior leads, with successful revascularization (TIMI grade 3 flow) of the lesion within 24 hours of symptoms and consented within 24 hours of procedure.

Exclusion Criteria

* Cardiogenic shock or hypotension, Systolic BP\< 90 mmHg or overt Congestive Heart Failure (CHF)
* Previous history of MI (Myocardial Infarction)
* Previous ECG suggesting previous MI
* Known Ejection Fraction (EF) \< 30%
* Atrial fibrillation
* Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease.
* Hemoglobin \<10 mg/dL
* Pregnant women/nursing mothers
* Participants still menstruating and have not been surgically sterilized must have a negative pregnancy test prior to participating in this study.
* Unable to undergo cardiac MRI (Magnetic Resonance Imaging).
* Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No