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Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study) (DECIDE)
This study has been completed.
Sponsor:
Vanderbilt University
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott Point of Care
Inovise Medical
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00911703
First received: May 29, 2009
Last updated: April 27, 2016
Last verified: December 2014
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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 |
Resource links provided by NLM:
Further study details as provided by Sean Collins, Vanderbilt University:
Primary Outcome Measures:
- Heart-failure related adverse events [ Time Frame: Measured 5 days and 30 days after ED presentation ]
| Enrollment: | 835 |
| Study Start Date: | August 2008 |
| Study Completion Date: | October 2015 |
| Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Acute heart failure
Subjects with an ED diagnosis of acute decompensated 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.
Criteria
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
The exclusion criteria are:
- Patients less than 18 years of age.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911703
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911703
Locations
| United States, Ohio | |
| University of Cincinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
National Heart, Lung, and Blood Institute (NHLBI)
Abbott Point of Care
Inovise Medical
Investigators
| Principal Investigator: | Sean P. Collins, MD, MSc | Vanderbilt University Emergency Medicine |
More Information
| 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 ( U.S. NIH Grant/Contract ) K23HL085387-01A2 ( U.S. NIH Grant/Contract ) |
| Study First Received: | May 29, 2009 |
| Last Updated: | April 27, 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
|
Heart Failure Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on September 18, 2017