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

Phase 4

Completed

• Conditions: Heart Failure, Congestive; Cardiomyopathy
• Interventions: Drug: recombinant B-type, natriuretic peptide; Drug: placebo

• Registration Number: NCT00559338
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2003-12
• Study Completion: 2005-04
• Status Verified: 2007-11
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-15
• Last Update Submitted: 2007-11-15
• Study First Posted: 2007-11-16
• Last Update Posted: 2007-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	recombinant B-type, natriuretic peptide	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.
2	placebo	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.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure of 30 day readmission to the ED or readmission after an 8-hr infusion of nesiritide, in addition to standard care, compared to placebo plus standard care	30-day

Secondary Outcome Measures

Name	Time	Method
Secondary outcome measures included admission to the hospital after an 8-hr infusion of nesiritide, return to the ED or readmission at 7 days, 60 days, and 90 days	90-days

Trial Locations

Locations (1)

Parkland Hospital; 🇺🇸 Dallas, Texas, United States