Brain Natriuretic Peptide (BNP) to Preserve Renal Function in Hospitalized Patients With Heart Failure

What Was Tested

In this phase 3 trial, researchers set out to test BNP (Nesiritide).

Patients hospitalized for treatment of decompensated heart failure (CHF) are at risk for prolonged length of stay (LOS) and frequent readmissions.

Renal dysfunction and diuretic resistance contribute to this risk, particularly if renal dysfunction worsens during CHF treatment.

Brain natriuretic peptide (BNP) is a hormone of myocardial cell origin with well-defined physiological effects which include arterial and venous vasodilation, suppression of adverse neurohumoral systems and favorable effects on renal hemodynamics and sodium excretion.

The registry classes the interventions as drug.

More on the Plan

The study is targeted at patients with mild to moderate renal dysfunction with adequate blood pressure who do not require inotropic therapy and are not felt to need intravenous vasodilator therapy for acute symptom control.

Patients will be randomized on admission to the heart failure service and prior to initiation of therapy.

Patients who receive initial therapy in the emergency department will be eligible but the therapy given in the emergency department will be recorded.

Creatinine, Creatinine Clearance at 1,2,3 days and at discharge 2.

Who Took Part

The registry lists 104 planned participants were the target.

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: Systolic BP \> 90. Stable cardiac rhythm. Unlikely to require cardiac catheterization.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: inability to give informed consent; new onset atrial fibrillation with rapid ventricular response (hr \>110 bpm); active ischemia.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

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

It started in 2003-03 with completion listed for 2007-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Creatinine, creatinine clearance on days 1, 2, & 3. Weight loss on days 1, 2 & 3. Fluid balance on days 1, 2 & 3.

It also tracked 4 secondary outcomes, for example Length of stay, 30-day re-admission for HF, Neuro-hormonal levels (PRA, A-II, ANP, BNP, cGMP, etc) and Hemodynamic measurements (systolic blood pressure [SBP], systolic blood pressure [DBP], mean arterial pressure [MAP]).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of BNP (Nesiritide) in 104 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.