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

This study has been terminated.
Sponsor:
Collaborator:
Scios, Inc.
Information provided by (Responsible Party):
Douglas Ander MD, Emory University
ClinicalTrials.gov Identifier:
NCT00453453
First received: March 28, 2007
Last updated: February 6, 2015
Last verified: February 2015
  Purpose
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 Intervention Phase
Congestive Heart Failure
Drug: Nesiritide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: BNP Therapy Observation Unit Outcomes STudy

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Number of subjects that return to the emergency department in 90 days [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between BNP levels at admission and number of subjects who return to the emergency department [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: March 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453453

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

Responsible Party: Douglas Ander MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT00453453     History of Changes
Other Study ID Numbers: IRB00038961  0009-2006 
Study First Received: March 28, 2007
Last Updated: February 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Congestive heart failure
observation unit
nesiritide

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

ClinicalTrials.gov processed this record on December 05, 2016