Clinical trial NCT00559338: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Heart Failure, Congestive
Cardiomyopathy
Keywords: CHF
Heart Failure
Dyspnea
Cardiomyopathy
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2007-11-16
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: 30-day
Secondary outcomes:
measure: 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
timeFrame: 90-days
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parkland Hospital
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center Dallas
name: Adam H Miller
role: PRINCIPAL_INVESTIGATOR
References: