A Study of Short-Term Outcomes and Economic Impact For Patients With Worsening Congestive Heart Failure When Natrecor (Nesiritide) is Added to Standard-Care Therapy, Compared to Administration of Placebo With Standard-Care Therapy

What Was Tested

In this phase 3 trial, researchers set out to test BNP (Nesiritide).

The purpose of this pilot study is to compare the clinical effects, safety profile, and economic impact of standard therapy plus Natrecor® (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to standard therapy plus placebo in patients who present to the Emergency Department with worsening congestive heart failure (CHF) and are treated in the Emergency Department /Observation Unit.

It had 1 arm (groups): 001 (experimental).

Natrecor (nesiritide).

The registry classes the interventions as drug.

More on the Plan

(according to Rich MW et al 1999 and O'Connell JB 2000).

Emergency Departments are the last line of defense against hospital admission for CHF.

Who Took Part

The registry lists 250 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: Patients with a history consistent with congestive heart failure (either chronic or new onset) with fluid overload or elevated cardiac filling pressures by clinical diagnosis. Having a need for observation and intravenous therapy for at least 12 hours, primarily for the treatment of acutely worsening heart failure.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: patients having a clinical status so acutely unstable that invasive monitoring or mechanical ventilation is required; admitted to emergency department/observation unit primarily for a diagnostic evaluation (such as ruling out myocardial infarction or to diagnose irregular heart beats); having systolic blood pressure consistently less than 90 mm hg.

How the Study Was Run

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

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.

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

It started in 2001-01 with completion listed for 2002-01.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Economic Impact on hospitals of earlier and more aggressive treatment in the Emergency Department with Natrecor® added to standard care.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 250 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.