BNP Therapy Observation Unit Outcomes STudy (BOOST)

NCT ID: NCT00453453

Last Updated: 2015-02-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2007-09-30

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nesiritide

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

Group Type: EXPERIMENTAL

Nesiritide

Intervention Type: DRUG

Nesiritide given orally in the emergency department

Standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nesiritide

Nesiritide given orally in the emergency department

Intervention Type: DRUG

Other Intervention Names

Natrecor

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scios, Inc.

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Douglas Ander MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Douglas Ander, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Daniel Wu, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Memorial Hosptial

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

0009-2006

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00038961

Identifier Type: -

Identifier Source: org_study_id