A Study to Develop Additional Safety and Clinical Experience With NATRECOR hBNP (Nesiritide) in the Treatment of Patients With Worsening Congestive Heart Failure Who Require Inpatient Intravenous Therapy With Medications That Influence the Tone and Caliber of Blood Vessels

What Was Tested

This registered phase 3 trial tested BNP (Nesiritide).

The purpose of this safety study is to evaluate NATRECOR® hBNP (a recombinant form of the natural human peptide normally secreted by the heart in response to heart failure), in subjects with worsening congestive heart failure for whom inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels is deemed appropriate.

The registry classes the interventions as drug.

More on the Plan

The duration of NATRECOR® hBNP therapy is determined by the attending physician.

The duration of NATRECOR® hBNP therapy is determined by the attending physician.

Who Took Part

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: Patients with a previous history of chronic congestive heart failure (CHF). Presenting with symptomatic, decompensated CHF for inpatient intravenous therapy with medications that influence the tone and caliber of blood vessels (other than, or in addition to, diuretics).

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: patients with myocardial ischemia within the past 48 hours; already being treated with iv therapy with medications that influence the tone and caliber of blood vessels that cannot be discontinued.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.

It started in 1997-01 with completion listed for 1997-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in symptoms and signs of CHF after 6 hours and after 24 hours of treatment with NATRECOR® hBNP.

It also tracked 1 secondary outcome, for example Adverse events, vital signs.

What This Means in Plain Language

Put simply, this is a phase 3, 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.