Nesiritide Infusion for the Treatment of Decompensated Heart Failure and Renal Dysfunction

What Was Tested

This registered phase 2 trial tested BNP (Nesiritide).

It had two arms (groups): Nesiritide + standard of care (experimental) and Standard of care (active comparator).

Standard of care until adequate diuresis achieved.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 34 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: Admission estimated creatinine clearance =\< 50 cc/min.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: systolic blood pressure \< 85 mm hg; cardiogenic shock; volume depletion.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got BNP (Nesiritide) and who got the comparison, which limits bias.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

Being open-label, the BNP (Nesiritide) study did not mask who received what.

It started in 2003-04 with completion listed for 2005-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Renal function (time frame: within 7 days after randomization).

It also tracked 5 secondary outcomes, for example Weight loss, Days to optimal volume status, Concomitant diuretic use, Global symptom assessment and Length of stay.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 34 people.

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

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.