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

NCT ID: NCT00911703

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

835 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Acute heart failure

Subjects with an ED diagnosis of acute decompensated heart failure .

No interventions assigned to this group

Eligibility Criteria

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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

Exclusion Criteria

* Patients less than 18 years of age.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Abbott Point of Care

INDUSTRY

Sponsor Role collaborator

Inovise Medical

INDUSTRY

Sponsor Role collaborator

Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Sean Collins

Associate Proffesor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean P. Collins, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Emergency Medicine

Locations

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University of Cincinnati

Cincinnati, Ohio, United States

Site Status

Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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K23HL085387-06

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23HL085387-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

659

Identifier Type: -

Identifier Source: org_study_id

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