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

Sponsor

University of Texas Southwestern Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00559338

Collaborator

Scios, Inc. (Industry)

104

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure, Congestive Cardiomyopathy	Drug: recombinant B-type, natriuretic peptide Drug: placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2003

Actual Study Completion Date :

Apr 1, 2005

Arms and Interventions

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.

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.