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

What Was Tested

In this phase 2 trial, researchers set out to test BNP (Nesiritide).

It had two arms (groups): Placebo (placebo comparator) and Nesiritide (active comparator).

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

The registry classes the interventions as drug.

More on the Plan

Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences.

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.

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.

Who Took Part

59 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 11 exclusion criteria; among the exclusions: cardiogenic shock or hypotension, systolic bp\< 90 mmhg or overt congestive heart failure (chf); previous history of mi (myocardial infarction); atrial fibrillation.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2006-09 with completion listed for 2012-11.

It ran at 2 sites in United States (2).

Its stated primary purpose is prevention.

What Was Measured

Researchers chose this as the main measure: Change in Left Ventricular End-Systolic Volume Index (time frame: baseline, 30 days).

It also tracked 2 secondary outcomes, for example Change in Left Ventricular End-Systolic Diastolic Volume Index and Myocardial Infarct Size at 30 Days.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 59 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the BNP (Nesiritide) compound page, all human trials.