Clinical Study to Evaluate Nesiritide in Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery A014 / NAPA

What Was Tested

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

The registry classes the interventions as drug.

More on the Plan

In coronary heart disease (CHD), the coronary arteries become clogged with calcium and fatty deposits.

The deposits, called plaques, narrow the arteries that carry blood to the heart muscle and could cause ischemic heart disease (too little blood and oxygen reaching the heart muscle).

Coronary Artery Bypass Graft (CABG) surgery is a treatment option for ischemic heart disease.

CABG surgery is surgery to create new routes for blood to flow around narrowed and blocked arteries so that the heart muscle will receive needed oxygen and nutrients.

Who Took Part

Enrollment: 305 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.

Examples of who could join: NYHA class II-IV CHF. Presenting for CABG with or without mitral valve repair or replacement procedure. Planned utilization of CPB.

The full record lists 4 inclusion and 14 exclusion criteria; among the exclusions: planned aortic valve replacement or repair; ongoing or chronic dialysis (either hemodialysis or continuous ambulatory peritoneal dialysis); restrictive or obstructive cardiomyopathy, constrictive pericarditis, pericardial tamponade, or other conditions in which cardiac output is dependent on venous return.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).

It started in 2004-03 with completion listed for 2005-06.

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): Change from baseline serum creatinine, total inotrope/vasopressor/vasodialator use during first 24 hours, average change from baseline of mean PAP for 24 hours from study start or after removal of catheter and 24-hour urine output after ICU/CCU admission.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 305 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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