BNP Therapy Observation Unit Outcomes STudy (BOOST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2007 by Emory University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Scios, Inc.
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00453453
First received: March 28, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

We hypothesize that patients admitted to an ED observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with natriuretic peptide versus standard therapy. We also hypothesize that decreasing B-type Natriuretic Peptide levels during treatment in an ED observation unit will predict these 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
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:
  • The primary aim of the study is to compare the natriuretic peptide therapy versus standard therapy in an ED observation unit setting. The main outcome measurement will be return visits to the ED at 90 days.

Secondary Outcome Measures:
  • A secondary aim is to determine if there is a correlation between serial BNP levels and return rates to the ED.

Estimated Enrollment: 270
Study Start Date: March 2007
Estimated Study Completion Date: March 2009
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 natriuretic peptide therapy has shown promising results in the treatment of decompensated congestive heart failure.

We hypothesize that patients admitted to an ED observation unit will have a decreased rate of hospital admissions and ED recidivism when treated with natriuretic peptides versus standard therapy. We also hypothesize that decreasing B-type Natriuretic Peptide levels during treatment in an ED observation unit will predict these patient outcomes.

The primary aim of this study is to compare natriuretic peptide therapy 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
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
  • Fever, T>38.5C
  • 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 MI 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

Contacts
Contact: Brittney L Copeland, BS 404.616.0301 brittney.copeland@emory.edu

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

No publications provided

ClinicalTrials.gov Identifier: NCT00453453     History of Changes
Other Study ID Numbers: 009-2006
Study First Received: March 28, 2007
Last Updated: March 28, 2007
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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014