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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:
ClinicalTrials.gov Identifier:
NCT00911703
First Posted: June 2, 2009
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott Point of Care
Inovise Medical
Information provided by (Responsible Party):
Sean Collins, Vanderbilt University
  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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 )
First Submitted: May 29, 2009
First Posted: June 2, 2009
Last Update Posted: April 29, 2016
Last Verified: December 2014
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases