An Efficacy and Safety Study for Nesiritide in Heart Failure Patients With Reduced Kidney Function Undergoing Coronary Artery Bypass Graft Surgery Requiring Cardiopulmonary Bypass (CPB Pump or Heart Lung Machine)

Plain-language guide to NCT00530361: phase 3 randomized trial of BNP (Nesiritide). Who took part, design and what was measured.

Key Facts

Registry ID: NCT00530361
Phase: phase 3
Status: withdrawn
Start: n/a
Completion (planned or actual): 2009-09
Participants: n/a (actual)
Design: randomized, double-blind, treatment
Conditions studied: Coronary Artery Bypass Surgery; Coronary Heart Disease; Coronary Artery Bypass Grafting; Cardiopulmonary Bypass; Ischemic Heart Disease; Heart Failure, Congestive
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around 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

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Patients with history of congestive heart failure. Scheduled to undergo coronary artery bypass graft (CABG) surgery with or without mitral valve replacement or repair on Cardiopulmonary Bypass machine.

The full record lists 4 inclusion and 9 exclusion criteria; among the exclusions: documented systemic bacterial/fungal/viral infection within 72 hours before surgery; known acute renal failure or ongoing chronic dialysis at baseline; planned aortic valve repair or replacement.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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

Our Notes on the Compound

BNP (Nesiritide): B-type natriuretic peptide, a 32-amino-acid heart hormone; nesiritide (Natrecor) is a recombinant form used in acute heart failure.

BNP (Nesiritide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.