Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Cardiomyopathy; Heart Failure, Congestive

Treatments: Drug: recombinant B-type, natriuretic peptide; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00559338

IRB0603-412

Details and patient eligibility

About

The purpose of this study is to determine if an 8hr infusion of nesiritide in the emergency department in the Acutely decompensated heart failure patients will decrease 30 day recidivism.

Full description

In view of the high return admission rate to our county ED for heart failure, we hypothesized that our higher risk patient population might realize a decrease in the return admission rate as a benefit from early ED administration of nesiritide. We also acknowledged that the safety of nesiritide in our patient population had not been well established. Thus, we opted to test the hypothesis that an 8-hour ED infusion of nesiritide [in addition to protocol specified standard therapy] in ADHF patients from an urban patient population consisting of predominately African Americans and Hispanics will decrease 30-day readmission rates without provoking harm.

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who were adults greater than 18 years of age
• A history of established heart failure
• Dyspnea at rest or with minimal exertion and with a respiratory rate greater than 24 breaths per minute
• Evidence of volume overload based on physical exam findings or chest radiograph, and a brain natriuretic peptide (BNP) level greater than 100 pg/ml.

Exclusion criteria

• Systolic blood pressure of less than 90 mm Hg
• Frank or impending cardiogenic shock
• Cardiopulmonary arrest
• Evidence of low cardiac output (cold clammy extremities
• Mental status changes)
• New onset congestive heart failure
• Suspected acute coronary syndrome (elevated troponin, New electrocardiographic changes, or history consistent with cardiac ischemia)
• High clinical suspicion of pulmonary embolism
• End-stage renal disease (on dialysis or imminent)
• Active use of nitroglycerin or inotropic infusions in the ED
• Ventricular tachycardia
• Allergy to nesiritide or its components
• Patient not needing intravenously diuretic therapy in the ED
• Normal BNP level
• Inability to follow-up
• Pregnancy or suspected pregnancy; or
• Actively receiving other investigational drug.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

The intravenous infusion of nesiritide consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The nesiritide was mixed in 250 ml of 0.9% normal saline solution.

Treatment:

Drug: recombinant B-type, natriuretic peptide

2

Placebo Comparator group

Description:

The intravenous infusion of placebo consisted of a bolus dose of 2mcg/kg followed by the infusion rate of 0.01 mcg/kg/min for up to eight hours. The placebo was mixed in 250 ml of 0.9% normal saline solution.

Treatment:

Drug: placebo