Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.

What Was Tested

This registered phase 1, phase 2 trial tested BNP (Nesiritide).

It had two arms (groups): BNP (nesiritide) (active comparator) and Placebo (placebo comparator).

Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator).

The registry classes the interventions as drug.

More on the Plan

Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot).

The participant will need to give themselves a shot in their stomach (similar to diabetics giving themselves insulin) twice a day for twelve weeks.

The study requires a screening visit to determine eligibility and discuss the study.

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.

The full record lists 2 inclusion and 14 exclusion criteria; among the exclusions: myocardial infarction (mi) within 3 months of screening; unstable angina within 14 days of screening, or any evidence of myocardial ischemia; sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

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.

Blinding on both sides kept the participants and researchers unaware of who received BNP (Nesiritide).

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2008-03 with completion listed for 2011-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Change in Urinary Sodium Excretion in Response to Saline Load (time frame: Baseline, 12 weeks).

It also tracked 3 secondary outcomes, for example Change in Urinary Flow in Response to Saline Load, Change in Glomerular Filtration Rate (GFR) in Response to Saline Load and Left Ventricular (LV) Filling Pressure.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 41 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.