A Study of the Safety and Efficacy of Follow-up Serial Infusions of Natrecor(Nesiritide) for the Management of Patients With Heart Failure

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

Heart Failure (HF) is the inability of the heart to pump efficiently and the heart cannot perform the necessary circulation of blood through the body.

This can result in symptoms like shortness of breath at rest or with minimal activity.

Patients enrolled in this study will receive nesiritide or placebo for up to 12 weeks.

Patients will then be followed for an additional 12 weeks.

Who Took Part

Enrollment: 920 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: Have documentation indicating that the patient was consistently New York Heart Association (NYHA) Class III or IV during the 60 days before randomization.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: have systolic blood pressure consistently \<90mm hg; had, or during the course of the study are anticipated to have, any organ transplantation (heart, liver, lung, kidney, or bone marrow); have cardiogenic shock, volume depletion, or any other clinical condition at the time of randomization that would contraindicate the administration of natrecor.

How the Study Was Run

Design: 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.

It started in 2004-04 with completion listed for 2006-12.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 920 people.

With 920 participants it is a large trial for this field.

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.