Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatments nesiritide versus placebo, nesiritide v. placebo
Phase phase 2
Sponsor Mayo Clinic
Start date September 2006
End date November 2012
Trial size 60 participants
Trial identifier NCT00573144, 06-002180

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Arm
(Placebo Comparator)
Infusion of Nesiritide versus Placebo
nesiritide versus placebo Nesiritide (Natrecor, BNP)
Infusion of 72 hours of IV nesiritide (Natrecor) at 0.006 mcg/kg/min as compared to placebo
(Active Comparator)
Infusion of Nesiritide v. placebo
nesiritide v. placebo Natrecor(BNP), Nesiritide
Infusion of 72 hours of IV nesiritide (Natrecor) at 0.006 mcg/kg/min as compared to placebo

Primary Outcomes

Measure
LV end systolic and diastolic dimensions determined by MUGA at 30 days as compared to baseline and between placebo group.
time frame: 30 days

Secondary Outcomes

Measure
EF and diastolic function determined by MUGA/ECHO at 30 days
time frame: 30 days
30 day combined total mortality and hospitalization for CHF
time frame: 30 days
Circulating ANP, BNP, ET and Aldosterone
time frame: 30 days
Infarct size and LV mass as determined by cardiac MRI
time frame: 30 days

Eligibility Criteria

Male or female participants at least 18 years old.

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 CHF - Previous history of MI - Previous ECG suggesting previous MI - Known EF < 30% - Atrial fibrillation - Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease. - Hemoglobin <10mg/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. Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.

Additional Information

Official title Nesiritide Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction
Principal investigator Horng H. Chen, M.D.
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, 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 CCU 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2012.
Information provided to ClinicalTrials.gov by Mayo Clinic.