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

Treatment Endpoints in Acute Decompensated Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 835

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute heart failure; Subjects with an ED diagnosis of acute decompensated heart failure .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart-failure related adverse events	Measured 5 days and 30 days after ED presentation

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: August 1, 2008
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: May 29, 2009
• First Submitted That Met QC Criteria: May 29, 2009
• First Posted (Estimate): June 2, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 659; K23HL085387-06 (U.S. NIH Grant/Contract); K23HL085387-01A2 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO