Acute Heart FailureDECIDENCT00911703
Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)
An observational study of Acute Heart Failure, run by Vanderbilt University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 835 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2008to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Cincinnati
Cincinnati, Ohio, 45267
Vanderbilt University
Nashville, Tennessee, 37232
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute heart failure | Subjects with an ED diagnosis of acute decompensated heart failure . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart-failure related adverse events
Measured: Measured 5 days and 30 days after ED presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2009 (estimated)
- Study startAug 2008
- Primary completionJul 2014
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Abbott Point of Care, Inovise Medical
- Responsible party
- Principal investigator, Sean Collins, Vanderbilt University
- Investigators
- Sean P. Collins, MD, MSc, Principal investigator, Vanderbilt University Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911703
- Sponsor's protocol ID
- 659
- Other IDs
- K23HL085387-06, K23HL085387-01A2
- Acronym
- DECIDE
- Status last verified
- Dec 2014
- First submitted
- 29 May 2009
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Endpoints in Acute Decompensated Heart Failure
- ClinicalTrials.gov ID
- NCT00911703
- Acronym / sponsor ID
- DECIDE / 659
- Conditions
- Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Abbott Point of Care, Inovise Medical
- Study start
- Aug 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 2 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute heart failure | – | –Subjects with an ED diagnosis of acute decompensated heart failure . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.
Key inclusion criteria (6 listed)
- 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
- Patients less than 18 years of age.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart-failure related adverse events
Time frame: Measured 5 days and 30 days after ED presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P. Collins, MD, MSc principal investigator
Vanderbilt University Emergency Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by Vanderbilt University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart-failure related adverse events (time frame: Measured 5 days and 30 days after ED presentation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.