Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (Believe II)

Mayo Clinic

Status and phase

Completed

Phase 2

Conditions

Acute Myocardial Infarction

Treatments

Drug: Placebo

Drug: Nesiritide

Study type

Interventional

Funder types

Other

Identifiers

NCT00573144

06-002180

Details and patient eligibility

About

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.

Full description

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.

Enrollment

59 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.