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

Primary Purpose

Congestive Heart Failure

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Congestive heart failure, observation unit, nesiritide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grady Memorial Hosptial

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Nesiritide

Standard care

Arm Description

Subjects who come into the ED with CHF will be treated with nesiritide

Subjects who come into the ED with CHF will receive standard care treatment

Outcomes

Primary Outcome Measures

Number of subjects that return to the emergency department in 90 days

Secondary Outcome Measures

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.

Full Information

First Posted
March 28, 2007
Last Updated
February 6, 2015
Sponsor
Emory University
Collaborators
Scios, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00453453
Brief Title
BNP Therapy Observation Unit Outcomes STudy (BOOST)
Acronym
BOOST
Official Title
BNP Therapy Observation Unit Outcomes STudy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Study Start Date
March 2007 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Scios, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Congestive heart failure, observation unit, nesiritide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nesiritide
Arm Type
Experimental
Arm Description
Subjects who come into the ED with CHF will be treated with nesiritide
Arm Title
Standard care
Arm Type
No Intervention
Arm Description
Subjects who come into the ED with CHF will receive standard care treatment
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Other Intervention Name(s)
Natrecor
Intervention Description
Nesiritide given orally in the emergency department
Primary Outcome Measure Information:
Title
Number of subjects that return to the emergency department in 90 days
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Correlation between BNP levels at admission and number of subjects who return to the emergency department
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Ander, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Daniel Wu, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hosptial
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States

12. IPD Sharing Statement

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BNP Therapy Observation Unit Outcomes STudy (BOOST)

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