Back to resultsImpact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department
Primary Purpose
Heart Failure, Congestive, Cardiomyopathy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
recombinant B-type, natriuretic peptide
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure, Congestive focused on measuring CHF, Heart Failure, Dyspnea, Cardiomyopathy
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.
Sites / Locations
- Parkland Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
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.
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.
Outcomes
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
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
Full Information
NCT ID
NCT00559338
First Posted
November 14, 2007
Last Updated
November 15, 2007
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Scios, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00559338
Brief Title
Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department
Official Title
Acutely Decompensated Heart Failure in a County Emergency Department: A Double Blind Randomized Controlled Comparison of Nesiritide vs. Placebo Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Scios, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive, Cardiomyopathy
Keywords
CHF, Heart Failure, Dyspnea, Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
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
Intervention Name(s)
recombinant B-type, natriuretic peptide
Other Intervention Name(s)
Nesiritide
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam H Miller
Organizational Affiliation
UT Southwestern Medical Center Dallas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkland Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Impact of Nesiritide Infusion for Decompensated Heart Failure in the Emergency Department
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