BNP Therapy Observation Unit Outcomes STudy (BOOST) (BOOST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00453453
Recruitment Status : Terminated
First Posted : March 29, 2007
Last Update Posted : February 9, 2015
Scios, Inc.
Information provided by (Responsible Party):
Douglas Ander MD, Emory University

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Drug: Nesiritide Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: BNP Therapy Observation Unit Outcomes STudy
Study Start Date : March 2007
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nesiritide
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Nesiritide
Subjects who come into the ED with CHF will be treated with nesiritide
Drug: 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

Primary Outcome Measures :
  1. Number of subjects that return to the emergency department in 90 days [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Correlation between BNP levels at admission and number of subjects who return to the emergency department [ Time Frame: 90 days ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00453453

United States, Georgia
Grady Memorial Hosptial
Atlanta, Georgia, United States, 30303
Sponsors and Collaborators
Emory University
Scios, Inc.
Principal Investigator: Douglas Ander, MD Emory University
Principal Investigator: Daniel Wu, MD Emory University

Responsible Party: Douglas Ander MD, Associate Professor, Emory University Identifier: NCT00453453     History of Changes
Other Study ID Numbers: IRB00038961
0009-2006 ( Other Identifier: Other )
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: February 9, 2015
Last Verified: February 2015

Keywords provided by Douglas Ander MD, Emory University:
Congestive heart failure
observation unit

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs