BNP for Cardio-Renal Decompensation Syndrome (BNP-CARDS)

What Was Tested

In this phase 4 trial, researchers set out to test BNP (Nesiritide).

The registry classes the interventions as drug.

More on the Plan

Heart failure represents a growing epidemic in the United States.

This growing incidence of heart failure is thought to be due to changing population demographics.

Renal insufficiency causes particular difficulty for the management of heart failure.

It has several actions in vivo, working as a diuretic, natriuretic and as a systemic pulmonary vasodilator.

Who Took Part

100 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.

Examples of who could join: Acute admission to hospital with CHF exacerbation.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: hypotension (sbp \< 90mmhg); hypertension (sbp \> 170 mmhg) necessitating vasodilator therapy; known allergy to natrecor.

How the Study Was Run

Design: randomized, single-group and double-blind.

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

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2004-03 with completion listed for 2006-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in serum creatinine (% and absolute) from admission to discharge- or at 7 days if patient still admitted.

It also tracked 7 secondary outcomes, for example Net negative diuresis at least 1 L/24 hours while on infusion, Change in plasma BNP levels (meas. at admission & d/c), Need to discontinue infusion due to symptomatic hypotension, Total diuretic use, Resource utilization (days in hospital etc.) and Need for inotropic therapy.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 100 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.