- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00453453
BNP Therapy Observation Unit Outcomes STudy (BOOST) (BOOST)
BNP Therapy Observation Unit Outcomes STudy
Study Overview
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
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Georgia
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Atlanta, Georgia, United States, 30303
- Grady Memorial Hosptial
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nesiritide
Subjects who come into the ED with CHF will be treated with nesiritide
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Nesiritide given orally in the emergency department
Other Names:
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No Intervention: Standard care
Subjects who come into the ED with CHF will receive standard care treatment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of subjects that return to the emergency department in 90 days
Time Frame: 90 days
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90 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between BNP levels at admission and number of subjects who return to the emergency department
Time Frame: 90 days
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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.
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90 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Douglas Ander, MD, Emory University
- Principal Investigator: Daniel Wu, MD, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00038961
- 0009-2006 (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congestive Heart Failure
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Adnan Kastrati, MDBiotronik SE & Co. KGCompleted
-
Signature Medical, Inc.WithdrawnHeart Failure,Congestive
-
Echosense Ltd.WithdrawnCongestive Heart Failure (CHF)United States
-
Corthera, Inc.(formerly BAS Medical, Inc.), a member...TerminatedCongestive Heart Failure (CHF)Russian Federation
-
Meir Medical CenterUnknown
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Nihon KohdenTerminatedHeart Failure,CongestiveUnited States
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ELA Medical, Inc.Approved for marketing
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Abbott Medical DevicesCompletedCongestive Heart Failure TreatedItaly
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Echosense Ltd.Terminated
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
Clinical Trials on Nesiritide
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Mayo ClinicNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsCompletedLeft Ventricular Diastolic DysfunctionUnited States
-
Janssen Pharmaceutical K.K.CompletedHeart Failure, CongestiveJapan
-
Mayo ClinicNational Institutes of Health (NIH)Completed
-
University of Wisconsin, MadisonScios, Inc.CompletedHeart Failure, CongestiveUnited States
-
The Baruch Padeh Medical Center, PoriyaUnknownCoronary Artery DiseaseIsrael
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Xian-Janssen Pharmaceutical Ltd.CompletedCongestive Heart Failure | Heart DecompensationChina
-
Mayo ClinicScios, Inc.CompletedKidney Diseases | Congestive Heart Failure | CardiomyopathyUnited States
-
Ejaz, Abulate A, MDUnknownCardiovascular Disease | Death | Acute Renal FailureUnited States
-
Shanghai Zhongshan HospitalUnknownCongestive Heart Failure | Mechanical Ventilation | Cardiac Function | Using Nesiritide | Venous ReturnChina
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Emory UniversityChildren's Healthcare of AtlantaWithdrawnHeart Failure | Ventricular Dysfunction | Heart Decompensation