Role of Natriuretic Peptides in the Treatment of Acutely Decompensated Heart Failure Patient With Obstructive Airways Disease

What Was Tested

This registered phase 3 trial tested BNP (Nesiritide).

Brain natriuretic peptide (BNP) is a useful therapy when treating patients with heart failure.

As many of these patients also have airways disease it is important to determine if BNP also has a positive effect on their respiratory condition.

It had two arms (groups): A (experimental) and B (placebo comparator).

Nesiritide.

Placebo.

The registry classes the interventions as drug.

Who Took Part

The registry lists 6 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: Males and females. Over 18 years of age. Confirmed written informed consent. Acute decompensated heart failure based on physicians assessment and requiring treatment as per standard emergency department protocols for this condition. Requirement for intravenous therapy of HF, e.g. diuretic, vasodilator.

The full record lists 10 inclusion and 6 exclusion criteria; among the exclusions: women lactating, pregnant or of childbearing potential not using 2 reliable contraceptive methods; patients who had received an investigational new drug within the last 4 weeks; patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind BNP (Nesiritide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2007-09 with completion listed for 2009-07.

It ran at 1 site in Australia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: To compare the need for and the length of time patients require non invasive ventilation when treated with nesiritide vs placebo (time frame: 24 hours).

It also tracked 1 secondary outcome, for example dyspnoea score respiratory rate FEV1 PEFR requirement for concomitant bronchodilator therapy BNP.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 6 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.