Clinical trial NCT00453453: BNP Therapy Observation Unit Outcomes STudy (BOOST)
Official title: BNP Therapy Observation Unit Outcomes STudy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Congestive Heart Failure
Keywords: Congestive heart failure
observation unit
nesiritide
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Scios, Inc.
First posted: 2007-03-29
Enrollment: 17
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 investigators hypothesize that patients admitted to an emergency department (ED) observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with nesiritide versus standard therapy. The investigators also hypothesize that decreasing B-type Natriuretic Peptide (BNP) levels during treatment in an ED observation unit will predict improved patient outcomes.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patient \> 18 years of age
* Have a working diagnosis of HF, as determined by the emergency physician using the Boston Criteria. A score of 8-12 is required for inclusion in the study.
* Alert, oriented and able to provide informed consent.
* Able to be contacted by telephone for follow up after discharge, and have none of the study exclusion criteria.

Exclusion Criteria:

* Dialysis Dependent Renal Failure
* Temperature \> 38.5 degrees celsius
* Pneumonia (Infiltrates on Chest X-ray)
* Requiring IV vasoactive agents (Other than Nesiritide)
* Killip Class III/IV
* Systolic blood pressure \< 90 mmHg
* EKG diagnostic or suggestive of Acute myocardial infarction or ischemia
* Abnormal Cardiac Markers
* Lack of a telephone
* Inability to provide informed consent due to cognitive impairment or a severe psychiatric disorder

Primary outcomes:
measure: Number of subjects that return to the emergency department in 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Correlation between BNP levels at admission and number of subjects who return to the emergency department
timeFrame: 90 days
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hosptial
state: Georgia
Study officials:
affiliation: Emory University
name: Douglas Ander, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Daniel Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: