A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure

What Was Tested

This registered phase 3 trial tested BNP (Nesiritide).

It had two arms (groups): 001 (experimental) and 002 (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Acute Decompensated Heart Failure (ADHF) is the inability of the heart to pump efficiently, which can result in symptoms like shortness of breath at rest or with minimal activity.

ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body.

Patient safety will be monitored throughout the study through physical exams, vital signs (heart rate, blood pressure, respiratory rate, and temperature), blood tests, and side effects.

The patients assigned to the placebo group will receive matching placebo bolus and infusion.

Who Took Part

Enrollment: 7141 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.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

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.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

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 2007-05 with completion listed for 2011-03.

It ran at 328 sites in United States (171), Canada (28), Australia (11), Brazil (11), China (8) and France (8).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite of Rehospitalization Due to Heart Failure and All-Cause Mortality (time frame: Randomization to Day 30). Dyspnea Self-Assessment at 6 Hours After Initiation of Study Drug (time frame: 6 hours after initiation of study drug). Dyspnea Self-Assessment at 24 Hours After Initiation of Study Drug (time frame: 24 hours after study drug initiation).

It also tracked 5 secondary outcomes, for example Overall Well-Being Self-Assessment at 6 Hours After Initiation of Study Drug, Overall Well-Being Self-Assessment at 24 Hours After Initiation of Study Drug, Composite of Persistent or Worsening Heart Failure and All-Cause Mortality, Number of Days Alive and Outside the Hospital and Composite of Cardiovascular Rehospitalization and Cardiovascular Mortality.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 7141 people.

With 7141 participants it is a large trial for this field.

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.