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Completed

NCT Number: NCT00559338

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Parkland Hospital

Dallas, Texas, 75390, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Nesiritide

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.

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

    Time frame: 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

    Time frame: 90-days

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • Scios, Inc.

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Nov 16, 2007
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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