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Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
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: September 3, 2013
Last verified: May 2009
  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 Vanderbilt University:

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: 500
Study Start Date: August 2008
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States
Sponsors and Collaborators
Vanderbilt University
Abbott Point-of-Care
Inovise Medical
Investigators
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: September 3, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 25, 2014