Double Blind Randomized Placebo Controlled Trial of Natrecor in Acute Decompensated Heart Failure With Normal EF

What Was Tested

This registered phase 4 trial tested BNP (Nesiritide).

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

Lactose, NF (monohydrate).

Natrecor (nesiritide) is a commercially available B-type natriuretic peptide which is indicated for intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea at rest or with minimal activity.

The registry classes the interventions as drug.

More on the Plan

The purpose of this study is to evaluate the utility of natriuretic peptide for the specific management of these patients.

Loop diuretics (such as Furosemide) are powerful diuretic agents which are used as a first-line therapy in volume overloaded patients with low ejection fraction heart failure.

These adverse effects are exacerbated even further in heart failure patients with normal ejection fraction since these patients are usually older, have worse renal function and are more susceptible to volume depletion and its effects.

Given however, the low number of patients with normal ejection fraction heart failure in clinical trials and the paucity of outcome data in these patients, the researchers propose to specifically study them.

Who 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: Patients greater than 18 years of age. Admission to the ED for congestive heart failure requiring IV diuretics and hospitalization. Chest X-ray evidence of pulmonary congestion (pleural effusion will not suffice). Physical evidence of volume overload i.e. rales or edema at time of randomization. Patients must be able to provide informed consent.

The full record lists 6 inclusion and 31 exclusion criteria; among the exclusions: hemodynamically unstable patients that require invasive monitoring or mechanical ventilation; systolic blood pressure \>220mmhg or diastolic blood pressure \>110mhg; systolic blood pressure consistently \<90 mmhg.

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.

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

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

It started in 2007-08 with completion listed for 2008-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example All cause in-hospital mortality, Physician and patient global score at 24 hours, Twenty-four hour urine output after start of study drug infusion and Weight change at 24 hours after start of study drug infusion.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the BNP (Nesiritide) compound page, all human trials.