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Sponsors and Collaborators: |
Emory University Scios, Inc. |
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Information provided by: | Emory University |
ClinicalTrials.gov Identifier: | NCT00453453 |
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 |
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Congestive Heart Failure |
Drug: Nesiritide |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | BNP Therapy Observation Unit Outcomes STudy |
Estimated Enrollment: | 270 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Brittney L Copeland, BS | 404.616.0301 | brittney.copeland@emory.edu |
United States, Georgia | |
Grady Memorial Hospital | Recruiting |
Atlanta, Georgia, United States, 30303 | |
Principal Investigator: Douglas Ander, MD | |
Sub-Investigator: Daniel Wu, MD |
Principal Investigator: | Douglas Ander, MD | Emory University |
Principal Investigator: | Daniel Wu, MD | Emory University |
Study ID Numbers: | 009-2006 |
Study First Received: | March 28, 2007 |
Last Updated: | March 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00453453 History of Changes |
Health Authority: | United States: Institutional Review Board |
Congestive heart failure observation unit nesiritide |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Cardiovascular Agents |
Natriuretic Peptide, Brain Heart Failure Heart Diseases Natriuretic Agents Therapeutic Uses |
Physiological Effects of Drugs Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |