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

NCT ID: NCT00559338

Last Updated: 2007-11-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2005-04-30

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.

Conditions

Heart Failure, Congestive; Cardiomyopathy

Keywords

CHF; Heart Failure; Dyspnea; Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

recombinant B-type, natriuretic peptide

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Nesiritide

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Adam H Miller

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern Medical Center Dallas

Locations

Parkland Hospital

Dallas, Texas, United States

Countries

United States

Other Identifiers

IRB0603-412

Identifier Type: -

Identifier Source: org_study_id