Rapid Assessment of Bedside BNP In Treatment of Heart Failure (RABBIT)

What Was Tested

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

To determine the clinical utility of using the Triage® BNP Test to guide therapy in outpatients with heart failure.

The registry classes the interventions as device.

More on the Plan

The Triage® BNP Test has been cleared by the U.S.

Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure.

Patients that are discharged after a hospitalization for heart failure will be approached for study enrollment.This is a multi-center, single (patient)-blinded cluster-randomized study.

Half of the sites will have BNP measurements available to guide therapy (experimental arm) and the other half of the sites will not have BNP measurements available (control arm).

Who Took Part

The registry lists 720 planned participants were the target.

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.

How the Study Was Run

The set-up was randomized, parallel-group and single-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.

In this single-blind BNP (Nesiritide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2003-07 with completion listed for 2006-04.

It ran at 29 sites in United States (29).

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Combined endpoint of mortality, unplanned clinic or hospital visits that require IV treatment for heart failure, and quality of life.

It also tracked 1 secondary outcome, for example All-cause re-hospitalization, Quality of Life, 6 minute walk distance, New York Heart Association class and BNP.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 720 people.

With 720 participants it is a large trial for this field.

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.