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

Acutely Decompensated Heart Failure in a County Emergency Department: A Double Blind Randomized Controlled Comparison of Nesiritide vs. Placebo Treatment

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure, Congestive; Cardiomyopathy
• Intervention / Treatment: Drug: recombinant B-type, natriuretic peptide; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Parkland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; 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.	Drug: 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.; Other Names: Nesiritide
Placebo Comparator: 2; 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Scios, Inc.
• Investigators: Principal Investigator: Adam H Miller, UT Southwestern Medical Center Dallas

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Study Completion (Actual): April 1, 2005

Study Registration Dates

• First Submitted: November 14, 2007
• First Submitted That Met QC Criteria: November 15, 2007
• First Posted (Estimate): November 16, 2007

Study Record Updates

• Last Update Posted (Estimate): November 16, 2007
• Last Update Submitted That Met QC Criteria: November 15, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Heart Failure; Cardiomyopathy; CHF; Dyspnea
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Heart Failure; Emergencies; Cardiomyopathies; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID Numbers: IRB0603-412