Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University
First received: May 29, 2009
Last updated: December 8, 2014
Last verified: December 2014
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Treatment Endpoints in Acute Decompensated Heart Failure
Primary Outcome Measures:
- Heart-failure related adverse events [ Time Frame: Measured 5 days and 30 days after ED presentation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||July 2014 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00911703
|University of Cincinnati
|Cincinnati, Ohio, United States, 45267 |
|Nashville, Tennessee, United States |
||Sean P. Collins, MD, MSc
||Vanderbilt University Emergency Medicine
No publications provided
||Sean Collins, Associate Proffesor of Emergency Medicine, Vanderbilt University
History of Changes
|Other Study ID Numbers:
||659, K23HL085387-06, K23 HL085387-01A2
|Study First Received:
||May 29, 2009
||December 8, 2014
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 28, 2015