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

NCT00559338 | Completed Phase 4

• 1 other identifier: IRB0603-412
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure, Congestive; Cardiomyopathy

Keywords

CHF; Heart Failure; Dyspnea; Cardiomyopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

recombinant B-type, natriuretic peptide 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.

Also known as: Nesiritide

1

placebo 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Scios, Inc.: collaborator

Study Sites (1)

Parkland Hospital

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Dyspnea

Interventions

Natriuretic Peptides; Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Adam H Miller

  UT Southwestern Medical Center Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: December 1, 2003
• Study Completion: April 1, 2005
• Last Updated: November 16, 2007

Record last verified: 2007-11

Locations

US (1)