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

Acute Heart Failure Clinical Trial

— DECIDE  

Official title:

Treatment Endpoints in Acute Decompensated Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911703
• Other study ID #: 659
• Secondary ID: K23HL085387-06K2
• Status: Completed
• Phase: N/A
• First received: May 29, 2009
• Last updated: April 27, 2016
• Start date: August 2008
• Est. completion date: October 2015

Study information

• Verified date: December 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 835
• Est. completion date: October 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (4)

Lead Sponsor	Collaborator
Vanderbilt University	Abbott Point-of-Care, Inovise Medical, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart-failure related adverse events		Measured 5 days and 30 days after ED presentation	Yes