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

This study has been completed.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00559338
First received: November 14, 2007
Last updated: November 15, 2007
Last verified: November 2007
  Purpose

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 Intervention Phase
Heart Failure, Congestive
Cardiomyopathy
Drug: recombinant B-type, natriuretic peptide
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

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 [ Time Frame: 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 [ Time Frame: 90-days ]

Enrollment: 104
Study Start Date: December 2003
Study Completion Date: April 2005
Arms Assigned Interventions
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 Name: 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.
Other Name: placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559338

Locations
United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Scios, Inc.
Investigators
Principal Investigator: Adam H Miller UT Southwestern Medical Center Dallas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00559338     History of Changes
Other Study ID Numbers: IRB0603-412
Study First Received: November 14, 2007
Last Updated: November 15, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
CHF
Heart Failure
Dyspnea
Cardiomyopathy

Additional relevant MeSH terms:
Heart Failure
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014