BNP Therapy Observation Unit Outcomes STudy (BOOST)

Congestive Heart Failure Clinical Trial

— BOOST  

Official title:

BNP Therapy Observation Unit Outcomes STudy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453453
• Other study ID #: IRB00038961
• Secondary ID: 0009-2006
• Status: Terminated
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: February 6, 2015
• Start date: March 2007
• Est. completion date: September 2007

Study information

• Verified date: February 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Nesiritide
Nesiritide given orally in the emergency department

Locations

Country	Name	City	State
United States	Grady Memorial Hosptial	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Scios, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects that return to the emergency department in 90 days		90 days	No
Secondary	Correlation between BNP levels at admission and number of subjects who return to the emergency department	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.	90 days	No