BNP Therapy Observation Unit Outcomes STudy (BOOST)

What Was Tested

The trial (phase 4) is built around BNP (Nesiritide).

It had two arms (groups): Nesiritide (experimental) and Standard care (no intervention).

Subjects who come into the ED with CHF will be treated with nesiritide.

Subjects who come into the ED with CHF will receive standard care treatment.

The registry classes the interventions as drug.

More on the Plan

Congestive heart failure (CHF) is a growing problem in the United States.

In addition, many of these patients will return to the ED for treatment within three months of being treated for decompensated heart failure.

The primary aim of this study is to compare nesiritide versus standard heart failure therapy in an ED setting.

A secondary aim is to determine if serial BNP levels during this observation unit stay will predict clinical outcomes.

Who Took Part

Enrollment: 17 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: Adult patient \> 18 years of age. Have a working diagnosis of HF, as determined by the emergency physician using the Boston Criteria. A score of 8-12 is required for inclusion in the study. Alert, oriented and able to provide informed consent. Able to be contacted by telephone for follow up after discharge, and have none of the study.

The full record lists 4 inclusion and 10 exclusion criteria; among the exclusions: dialysis dependent renal failure; temperature \> 38.5 degrees celsius; pneumonia (infiltrates on chest x-ray).

How the Study Was Run

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

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.

Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2007-03 with completion listed for 2007-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of subjects that return to the emergency department in 90 days (time frame: 90 days).

It also tracked 1 secondary outcome, for example Correlation between BNP levels at admission and number of subjects who return to the emergency department.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 17 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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