BNP Therapy Observation Unit Outcomes STudy (BOOST)

Emory University

Status and phase

Terminated

Phase 4

Conditions

Congestive Heart Failure

Treatments

Drug: Nesiritide

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00453453

0009-2006 (Other Identifier)

IRB00038961

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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