An Open-label, One-arm, Study to Evaluate the Hemodynamic Changes and Safety of Nesiritide for Acute Decompensated Heart Failure

What Was Tested

In this phase 3 trial, researchers set out to test BNP (Nesiritide).

It had 1 arm (groups): Nesiritide (experimental).

The registry classes the interventions as drug.

More on the Plan

The study was conducted in hospital setting and all patients exhibited symptoms of acute decompensated heart failure, requiring treatment with intravenous drug administration.

The total duration was 180 days, including a screening phase, an open treatment phase (24 hours in all) and a safety follow-up phase (day 30 and day 180).

Screening phase: Right heart floating catheter was placed for patients with acute decompensate heart failure who met the inclusion criteria while not the exclusion criteria to measure pulmonary capillary wedge pressure.

The results should be =20 mmHg.

Who Took Part

41 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: Systolic blood pressure\> 90 mmHg. The subjects must present with dyspnoea at resting state or with minimum activity amount (such as standing up). Onset at this time was complicated with symptoms of acute decompensate heart failure, and it was serious enough to call for hospitalization and treatment with intravenous drug administration. Acute decompensate heart failure was caused by cardiogenic factors rather than pulmonary factors (for example, it was neither cor pulmonale nor chronic heart failure complicated with pneumonia). The patients must have at least two of manifestations that related with this acute onset.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: patients with systolic blood pressure =90 mmhg; patients who had been administered with intravenous nitroglycerin or other intravenous vasoactive drugs within 2 hour before administration of the investigational drug; patients with such extremely emergent and unstable clinical conditions that not tolerant to swan-ganz catheter or temporal baseline evaluation.

How the Study Was Run

The set-up was randomized, single-group and open-label.

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

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

It started in 2006-10 with completion listed for 2007-06.

It ran at 4 sites in China (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in pulmonary capillary wedge pressure (time frame: Baseline, 180 days).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 41 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.