Nesiritide in Chronic Heart Failure

What Was Tested

This registered phase 2 trial tested BNP (Nesiritide).

Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries.

Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure.

The registry classes the interventions as drug.

More on the Plan

This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure.

It is double-blinded, which means that the neither subject nor their study doctor will know which study drug the subject will receive.

However, in an emergency, this information can be obtained quickly.

The study is placebo-controlled, which means subjects will not receive study drug at some point during the study; however because it is a cross-over study, subjects will be receiving nesiritide at some point in the study.

Who Took Part

20 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: Frequent hospitalizations or ER visits (\>1/month on average).

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: nesiritide infusion \>24 hours in the previous 30 days; stable chronic heart failure or nyha class i or ii; aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.

How the Study Was Run

Design: randomized, crossover and double-blind.

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

In the crossover set-up each of the participants took both BNP (Nesiritide) and the comparison in turn, acting as their own control.

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

It started in 2003-08 with completion listed for 2006-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in NYHA status (time frame: Day 0, Day 42).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 20 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.