Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)
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Purpose
The purpose of this study is to determine if certain findings (blood tests, symptom improvement, etc.) after acute heart failure treatment can identify a group of patients who are safe for early hospital discharge.
| Condition |
|---|
|
Acute Heart Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Treatment Endpoints in Acute Decompensated Heart Failure |
- Heart-failure related adverse events [ Time Frame: Measured 5 days and 30 days after ED presentation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2016 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Acute heart failure |
Detailed Description:
A fundamental question faced by physicians treating acute decompensated heart failure (ADHF) is "When has treatment worked sufficiently for safe discharge, and who requires further treatment?" Patients with ADHF have a high incidence of morbidity and mortality. Current guidelines for emergency department (ED) and hospital disposition of patients with ADHF are based on limited empirical evidence. This creates clinical uncertainty regarding disposition leads to prolonged hospitalizations, higher costs and increased resource consumption. The specific aim of the study is to develop a prediction rule from readily available clinical data to help physicians identify ADHF patients eligible for safe and early discharge from the ED and hospital after treatment is initiated.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.
Inclusion Criteria:
- Fulfill the modified Framingham criteria
- Have baseline data available within 1 hour of initial ED therapy
- Have previously documented systolic dysfunction (ejection fraction less than 50%) by echocardiogram
- Willing and able to give informed consent
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00911703
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States | |
| Principal Investigator: | Sean P. Collins, MD, MSc | Vanderbilt University Emergency Medicine |
More Information
No publications provided
| Responsible Party: | Sean Collins, Associate Proffesor of Emergency Medicine, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00911703 History of Changes |
| Other Study ID Numbers: | 659, K23HL085387-06, K23 HL085387-01A2 |
| Study First Received: | May 29, 2009 |
| Last Updated: | December 8, 2014 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Heart Failure Cardiovascular Diseases Heart Diseases |
ClinicalTrials.gov processed this record on February 25, 2015