A Study Comparing Blood Flow and Clinical and Safety Effects of the Addition of Natrecor (Nesiritide), Placebo or Intravenous Nitroglycerin to Standard Care for the Treatment of Worsening Congestive Heart Failure.

What Was Tested

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

The purpose of this study is to compare the hemodynamic (blood flow) and clinical effects of the study drug, Natrecor (nesiritide, a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure) to those of intravenous nitroglycerin or placebo, when added to the standard care therapy that is usually administered in the treatment of patients with worsening congestive heart failure.

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

Nesiritide.

The registry classes the interventions as drug.

More on the Plan

Despite medical advances, some patients are unresponsive to the oral medications used to treat CHF and require added therapy.

Such patients are typically New York Heart Association (NYHA) Class III and IV, and require intravenous (IV) therapy with inotropic agents.

Inotropic agents are drugs that influence muscular contractility.

However, many patients have a condition of dilated cardiomyopathy, an abnormality of the heart muscle wall in which the walls of the heart become stretched and weakened, with no easily identifiable cause.

Who Took Part

Enrollment: 498 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 dyspnea (difficulty breathing and shortness of breath) at rest, while supine, or immediately upon minimal activity such as talking, eating, or bathing. Having elevated cardiac filling pressures either by clinical estimate in non-catheterized patients, or a measured pulmonary capillary wedge pressure (PCWP) \>= 20 mm Hg in catheterized patients. Requiring hospitalization and intravenous therapy for at least 24 hours for the treatment of acutely decompensated heart failure.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: NPatients having systolic blood pressure consistently less than 90 mm Hg; having their most recent pulmonary capillary wedge pressure (pcwp) \< 20 mm hg within 24 hours before randomization; having a clinical status so acutely unstable that the potential subject could not tolerate placement of a right heart catheter or the 3-hour placebo period.

How the Study Was Run

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

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.

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

It started in 1999-10 with completion listed for 2000-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change from baseline to 3 hours after the start of study drug in PCWP (pulmonary capillary wedge pressure) in subjects who have right heart catheters; Change from baseline in dyspnea (difficult breathing) 3 hours after the start study drug.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 498 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.