Heart FailureACUTENCT02634762
Acute Congestive Heart Failure Urgent Care Evaluation
An observational study of Heart Failure, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
Trial summary
This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 1,983 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2011to Dec 2017
- How long will I take part?
- 30 Days
- 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 diagnosed with heart failure at 8 centers in Ontario, Canada
Who may be able to join
- Patients with acute heart failure diagnosed in the emergency department
Who cannot join
- Palliative or do-not-resuscitate (DNR) directive
- Dialysis dependent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Congestive Heart Failure Urgent Care Evaluation: Prospective Validation of the Emergency Heart Failure Mortality Risk Grade 7-day and 30-day Algorithms in the Emergency Department
This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST) have been previously derived.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death within 7 days after emergency department presentation for heart failure
Measured: 7 days
Mortality
Death within 30 days after emergency department presentation for heart failure
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startJan 2011
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 1,983 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Institute for Clinical Evaluative Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Douglas Lee, Institute for Clinical Evaluative Sciences
- Investigators
- Douglas Lee, MD, PhD, Principal investigator, Institute for Clinical Evaluative Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634762
- Sponsor's protocol ID
- 1
- Acronym
- ACUTE
- Status last verified
- Mar 2018
- First submitted
- 16 Dec 2015
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Lee DS, Lee JS, Schull MJ, Borgundvaag B, Edmonds ML, Ivankovic M, McLeod SL, Dreyer JF, Sabbah S, Levy PD, O'Neill T, Chong A, Stukel TA, Austin PC, Tu JV. Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure. Circulation. 2019 Feb 26;139(9):1146-1156. doi: 10.1161/CIRCULATIONAHA.118.035509.
PubMed 30586748
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Congestive Heart Failure Urgent Care Evaluation: Prospective Validation of the Emergency Heart Failure Mortality Risk Grade 7-day and 30-day Algorithms in the Emergency Department
- ClinicalTrials.gov ID
- NCT02634762
- Acronym / sponsor ID
- ACUTE / 1
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,983 participants (actual)
- Lead sponsor
- Institute for Clinical Evaluative SciencesUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2015 (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.
This prospective validation study evaluates the ability of a risk algorithm, which can simultaneously predict the risk of death at 7 days and 30 days for patients with acute heart failure presenting to the emergency department. The risk algorithms for prediction of 7-day (Emergency Heart failure Mortality Risk Grade [EHMRG]) and 30-day mortality (EHMRG30-ST) have been previously derived.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
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 diagnosed with heart failure at 8 centers in Ontario, Canada
Key inclusion criteria (1 listed)
- Patients with acute heart failure diagnosed in the emergency department
Key exclusion criteria (2 listed)
- Palliative or do-not-resuscitate (DNR) directive
- Dialysis dependent
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
Mortality
Time frame: 7 days
Death within 7 days after emergency department presentation for heart failure
Mortality
Time frame: 30 days
Death within 30 days after emergency department presentation for heart failure
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 Mar 2018.
- Derived from this study: PubMed 30586748Lee DS, Lee JS, Schull MJ, Borgundvaag B, Edmonds ML, Ivankovic M, McLeod SL, Dreyer JF, Sabbah S, Levy PD, O'Neill T, Chong A, Stukel TA, Austin PC, Tu JV. Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure. Circulation. 2019 Feb 26;139(9):1146-1156. doi: 10.1161/CIRCULATIONAHA.118.035509.
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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.
Douglas Lee, MD, PhD principal investigator
Institute for Clinical Evaluative Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Institute for Clinical Evaluative Sciences at 1 site in Canada.
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 1 inclusion and 2 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Mortality (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02634762, which also lists 1 linked publication.
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 Mar 2018.