A Safety Study Comparing Natrecor (Nesiritide) Versus Dobutamine Therapy for Worsening Congestive Heart Failure

What Was Tested

This registered phase 3 trial tested BNP (Nesiritide).

It had 1 arm (groups): 001 (experimental).

Nesiritide.

The registry classes the interventions as drug.

More on the Plan

The ventricle is the heart's pumping chamber that pumps the oxygen-poor blood returning from the body into the arteries of the lungs, where the blood picks up oxygen.

Clinical symptoms are also measured.

This is a multicenter, randomized, open-label, active-controlled safety study designed to enroll approximately 240 patients with symptomatic (New York Heart Association \[NYHA\] Class III or IV), decompensated CHF for whom treatment with dobutamine or Natrecor® is deemed appropriate.

The randomization is stratified by whether or not the subjects have a known history of Ventricular Tachycardia (non-sustained or sustained).

Who Took Part

255 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: History of NYHA (New York Heart Association) Class III or IV congestive heart failure (CHF).

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: has a clinical condition expected to require therapy with more than one intravenous vasoactive agent or dopamine during the 24-hour treatment holter monitoring period; requires an intravenous antiarrhythmic medication during the 48 hours before starting the study.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Everyone knew when BNP (Nesiritide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 1998-08 with completion listed for 1999-02.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Average heart rate; average hourly premature ventricular beats; average hourly repetitive beats, all expressed as a change from baseline.

It also tracked 1 secondary outcome, for example Incidence of tachycardia through 24 hours; Incidence of tachycardia, pain, and injection site reaction through 14 days .

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 255 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.