NCT00911703

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
835

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

April 29, 2016

Status Verified

December 1, 2014

Enrollment Period

5.9 years

First QC Date

May 29, 2009

Last Update Submit

April 27, 2016

Conditions

Acute Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Heart-failure related adverse events

    Measured 5 days and 30 days after ED presentation

Study Arms (1)

Acute heart failure

Subjects with an ED diagnosis of acute decompensated heart failure .

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.

You may qualify if:

  • 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

You may not qualify if:

  • Patients less than 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Study Officials

  • Sean P. Collins, MD, MSc

    Vanderbilt University Emergency Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Proffesor of Emergency Medicine

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

August 1, 2008

Primary Completion

July 1, 2014

Study Completion

October 1, 2015

Last Updated

April 29, 2016

Record last verified: 2014-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)