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

Heart Failure, Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559338
• Other study ID #: IRB0603-412
• Status: Completed
• Phase: Phase 4
• First received: November 14, 2007
• Last updated: November 15, 2007
• Start date: December 2003
• Est. completion date: April 2005

Study information

• Verified date: November 2007
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy
• Heart Failure
• Heart Failure, Congestive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Parkland Hospital	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Scios, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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