BNP Therapy Observation Unit Outcomes STudy (BOOST) (BOOST)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||BNP Therapy Observation Unit Outcomes STudy|
- Number of subjects that return to the emergency department in 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]
- Correlation between BNP levels at admission and number of subjects who return to the emergency department [ Time Frame: 90 days ] [ Designated as safety issue: No ]The BNP levels per subject will be plotted to their return rate to the emergency department. Pearson correlation coefficient will be calculated to explore their relationship. Pearson correlation coefficient is a measure of the linear correlation (dependence) between 2 variables, giving a value between +1 and −1 inclusive, where 1 is total positive correlation, 0 is no correlation, and −1 is total negative correlation.
|Study Start Date:||March 2007|
|Study Completion Date:||September 2007|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Subjects who come into the ED with CHF will be treated with nesiritide
Nesiritide given orally in the emergency department
Other Name: Natrecor
No Intervention: Standard care
Subjects who come into the ED with CHF will receive standard care treatment
Congestive heart failure (CHF) is a growing problem in the United States. The increasing number of decompensated heart failure patients presenting to emergency departments (ED) for treatment is worsening the burden on already strained and limited health care resources. In addition, many of these patients will return to the ED for treatment within three months of being treated for decompensated heart failure. The emergence of ED observation units has provided a viable and cost effective alternative to inpatient treatment for many diseases including CHF. It has been shown that intensive, directed therapy in ED observation units has decreased the revisit rates for CHF patients. In addition, the introduction of nesiritide has shown promising results in the treatment of decompensated congestive heart failure.
The primary aim of this study is to compare nesiritide versus standard heart failure therapy in an ED setting. A secondary aim is to determine if serial BNP levels during this observation unit stay will predict clinical outcomes.
The treatment of heart failure in the ED places a tremendous burden on already limited resources. The costs of treatment as well as the morbidity and mortality associated with the disease are worsening and are predicted to increase as the general population ages. The ability to safely treat and discharge patients from an ED observation unit while reducing return visits would be invaluable in managing the growing number of heart failure patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453453
|United States, Georgia|
|Grady Memorial Hosptial|
|Atlanta, Georgia, United States, 30303|
|Principal Investigator:||Douglas Ander, MD||Emory University|
|Principal Investigator:||Daniel Wu, MD||Emory University|