An Exploratory Study of Nesiritide in Participants With Acute Heart Failure

What Was Tested

The trial (phase 2) is built around BNP (Nesiritide).

It had three arms (groups): Nesiritide (1+0.01) (experimental), Nesiritide (2+0.005) (experimental) and Nesiritide (2+0.01) (experimental).

The registry classes the interventions as drug.

More on the Plan

The study consists of 3 periods: Observation period (from the time of obtaining consent to the start of study treatment), Treatment period, and Follow-up period (from 24 hours after the initiation of study treatment \[discontinuation\] to 30 days after the initiation of study treatment).

The participants will be randomly assigned to 1 of the following 3 treatment groups: 2+0.005 group, 1+0.01 group and 2+0.01 group.

Then participants will be followed up to a maximum of 30 days after the initiation of study treatment, in follow-up period.

Participants will primarily be evaluated for the effect of nesiritide on hemodynamic parameters such as pulmonary capillary wedge pressure (PCWP), or if it is unmeasurable then it will be complemented with pulmonary arterial diastolic pressure (PADP).

Who Took Part

67 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: participants who are or may be pregnant or breast-feeding; participants receiving non-invasive (puncture, opening or cutting of the skin) positive pressure ventilation (nippv) or scheduled to receive this during the study period; participants who received prohibited concomitant medications within 3 hours before the initiation of investigational treatment or those who are receiving such a medication.

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 2007-03 with completion listed for 2008-06.

It ran at 11 sites in Japan (11).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP or Pulmonary Arterial Diastolic Pressure[PADP]) at 3 Hours (time frame: Baseline and 3 Hours).

It also tracked 19 secondary outcomes, for example Change From Baseline in Mean Right Atrial Pressure (MRAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 15 and 24 Hour, Change From Baseline in Pulmonary Arterial Systolic Pressure (PASP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour, Change From Baseline in Pulmonary Arterial Diastolic Pressure (PADP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour, Change From Baseline in Mean Pulmonary Arterial Pressure (MPAP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour, Change From Baseline in Pulmonary Capillary Wedge Pressure (PCWP) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour and Change From Baseline in Cardiac Output (CO) at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 9, 12, 15 and 24 Hour.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 67 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the BNP (Nesiritide) compound page, all human trials.