Human B-type Natriuretic Peptide (BNP) (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function

What Was Tested

The trial (phase 1, phase 2) is built around BNP (Nesiritide).

Patients will complete a 6-minute walk test.

Patients will be instructed to follow a no-added-salt diet for 1-3 weeks before the study and for the whole duration of the study.

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

After enrollment, the study lasts for twelve weeks.

Who Took Part

37 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

The full record lists 5 inclusion and 14 exclusion criteria; among the exclusions: myocardial infarction 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

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

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

Neither the participants nor the staff measuring them knew who was on BNP (Nesiritide), so expectations could not easily colour the readings.

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

It started in 2006-06 with completion listed for 2011-04.

It ran at 1 site in United States.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: 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 Urine Flow in Response to Saline Load, Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) in Response to Saline Load and Change in Left Ventricular Mass Index.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 37 people.

Its size is small, so on its own it can only give an early look.

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.