Cardiac Hormone Replacement With Brain Natriuretic Peptide (BNP) in Heart Failure

What Was Tested

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

It had two arms (groups): B-type Natriuretic Peptide (BNP) (active comparator) and Placebo (placebo comparator).

Placebo self-administered subcutaneously twice daily for 8 weeks.

The registry classes the interventions as drug and other.

More on the Plan

Studies have established that BNP mediates natriuresis, renin and aldosterone (RAAS) inhibition, vasodilation and lusitropism.

However, chronic cardiac hormone replacement with BNP as therapeutic strategy in CHF has been limited by the need to administer BNP intravenously.

The objective of this study is to define the cardiorenal and humoral actions of short term (eight weeks) chronic cardiac hormone replacement with subcutaneous (SQ) BNP in human NYHA class II-III CHF.

Systolic and diastolic function, left ventricular remodeling as assessed by its volume, renal function, neurohumoral profiling and exercise capacity will be assessed prior to and after eight weeks of treatment.

Who Took Part

The registry lists 45 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: Age \> 18 years. Female subjects not menopausal or surgically sterilized will need to have a negative pregnancy test the day before the study day and be on contraception.

The full record lists 4 inclusion and 21 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; valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.

How the Study Was Run

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

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 2000-01 with completion listed for 2008-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in Left Ventricular (LV) Volume Index at 8 Weeks (time frame: Baseline and 8 weeks). Change in Left Ventricular (LV) Mass Index at 8 Weeks (time frame: Baseline and 8 weeks).

It also tracked 6 secondary outcomes, for example Change in Left Ventricular (LV) Filling Pressure at 8 Weeks, Change in Plasma Renin Activity at 8 Weeks, Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks and Change in Left Ventricular Ejection Fraction at 8 Weeks.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized trial of BNP (Nesiritide) in 45 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.