Assessment of Biomarkers and Cardiorenal Syndrome in Acute Decompensated Heart Failure With Vasodilator Therapy

What Was Tested

The trial (phase 4) is built around BNP (Nesiritide).

It had two arms (groups): Nesiritide Infusion (experimental) and Nitroglycerin Infusion (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 89 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: At least 18 years of age. Baseline systolic blood pressure ≥ 90 mm Hg at the time of enrollment. Neither pregnant or breastfeeding at the time of enrollment. Authorization of patient's enrollment by patient's medical provider.

The full record lists 6 inclusion and 8 exclusion criteria; among the exclusions: \<18 years of age; denies written informed consent; pregnant or lactating.

How the Study Was Run

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

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

Nothing was hidden in this open-label BNP (Nesiritide) study: the participants and staff both knew the treatment.

It started in 2006-07 with completion listed for 2008-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Renal Function by Serum Creatinine (time frame: Baseline, 24 hours, 48 hours).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of BNP (Nesiritide) in 89 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.