STARBRITE: A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure

What Was Tested

The trial (phase 2) is built around BNP (Nesiritide).

It had two arms (groups): Congestion Score Strategy (other) and BNP Strategy (other).

The registry classes the interventions as device and other.

More on the Plan

Individual targets for each patient will be based on the outcome of the index hospitalization, during which therapy is adjusted to optimize clinical status, blood pressure, and renal function.

Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients.

In addition, a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings.

In this study, patients will be randomized to two strategies of outpatient fluid management: 1) the Congestion Score Strategy and, 2) the BNP Strategy.

Who Took Part

Enrollment: 135 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: Has regular access to a telephone. ≥18 years of age.

The full record lists 7 inclusion and 5 exclusion criteria; among the exclusions: moderate to severe valvular stenosis; admitted with acute coronary syndrome; creatinine \>3.5.

How the Study Was Run

Design: randomized, parallel-group and single-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.

Only one side, usually the participants, was kept unaware of whether BNP (Nesiritide) was given.

It started in 2003-02 with completion listed for 2005-08.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of days neither hospitalized nor dead from the date of the first clinic visit to 90 days thereafter (time frame: 90 day follow up).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 135 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.