Heart FailureNCT05710302
Prospective Validation of the Emergency Heart Failure Mortality Risk Grade (EHMRG) Score in Patients With Acute Heart Failure in the Emergency Department
An observational study of Heart Failure and Heart Diseases, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective validation study, researchers investigates accuracy of EHMRG (Emergency Heart Failure Mortality Risk Grade) score in predicting the 7th and 30th day risk of mortality in patients with acute heart failure who applying 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, Heart Diseases, Acute Heart Failure
- What is being tested?
- Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure
- How many people
- 239 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2022to 24 Jan 2023
- 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 diagnosed with acute heart failure in the emergency department.
Who may be able to join
- Patients diagnosed with acute heart failure in the emergency department
Who cannot join
- Dialysis dependent patients
- Pregnant patients
- Patients brought to the emergency department with cardiac arrest
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Pendik Training and Research Hospital
Istanbul
About this study
Official title: Investigation of the Diagnostic Accuracy of EHMRG Risk Score in Patients With Acute Heart Failure
In this prospective validation study, researchers investigates accuracy of EHMRG (Emergency Heart Failure Mortality Risk Grade) score in predicting the 7th and 30th day risk of mortality in patients with acute heart failure who applying to the emergency department.
Read the detailed description
Heart failure is a serious public health problem in the world due to its high morbidity and mortality rate.Turkish Society of Cardiology conducted a prevalence study. The name of the study is HAPPY. Accordingly, the prevalence of heart failure in people over 35 years of age in Turkey is 2.9%.The prevalence of heart failure in Turkey is higher than in European countries.
The incidence of heart failure cases with no obvious symptoms is 4.9% in Turkey. Patients with a diagnosis of heart failure apply to the emergency department frequently. There are scoring studies around the world for patients' hospitalization and discharge.
EHMRG score created and validated by Douglas S. Lee et al. In our study, the accuracy of EHMRG score will be investigated prospectively in patients diagnosed with acute heart failure in the emergency department.
- Conditions
- Heart Failure, Heart Diseases, Acute Heart Failure
- Being tested
- Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure
- Keywords
- mortality, emergency department, heart failure, hospitalization, risk assessment, discharge planning
- Medical subject headings
- Heart Failure, Heart Diseases, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failureOther
Prospective validation of the EHMRG score in patients with acute heart failure in the emergency department
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with acute heart failure in the emergency department | Patients with acute heart failure. Receives: Other: Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute 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 acute heart failure.
Measured: 7 days
Mortality
Death within 30 days after emergency department presentation for acute 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 posted2 Feb 2023
- Study start29 Jul 2022
- Primary completion3 Sep 2022
- Study completion24 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University Pendik Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berkay Ünlü, Marmara University Pendik Training and Research Hospital
- Investigators
- Berkay UNLU, MD, Principal investigator, Marmara University School of Medicine Emergency Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05710302
- Sponsor's protocol ID
- 09.2022.742
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study plan, collected data and statistical analyzes will be shared with the researchers.
Publications
Lee DS, Lee JS, Schull MJ, Grimshaw JM, Austin PC, Tu JV. Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study. Am Heart J. 2016 Nov;181:60-65. doi: 10.1016/j.ahj.2016.07.016. Epub 2016 Aug 7.
PubMed 27823694van Hattem NE, Beeres SLMA, Mertens BJA, Antoni ML, Atsma DE, Schalij MJ, den Haan MC. Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions. Neth Heart J. 2022 Sep;30(9):431-435. doi: 10.1007/s12471-022-01661-3. Epub 2022 Mar 11.
PubMed 35277803Lee 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 30586748Lee DS, Stitt A, Austin PC, Stukel TA, Schull MJ, Chong A, Newton GE, Lee JS, Tu JV. Prediction of heart failure mortality in emergent care: a cohort study. Ann Intern Med. 2012 Jun 5;156(11):767-75, W-261, W-262. doi: 10.7326/0003-4819-156-11-201206050-00003.
PubMed 22665814Unlu B, Demir O, Ozpolat C, Altunbas E, Denizbasi A. External prognostic validation of the EHMRG score for risk stratification and disposition decisions in acute heart failure. BMC Emerg Med. 2026 Apr 6;26(1):145. doi: 10.1186/s12873-026-01573-0.
PubMed 41942909
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Diagnostic Accuracy of EHMRG Risk Score in Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT05710302
- Acronym / sponsor ID
- 09.2022.742
- Conditions
- Heart Failure, Heart Diseases, Acute Heart Failure
- Keywords
- mortality, emergency department, heart failure, hospitalization, risk assessment, discharge planning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Marmara University Pendik Training and Research HospitalUniversity, hospital or other
- Study start
- 29 Jul 2022 (actual)
- Primary completion
- 3 Sep 2022 (actual)
- Study completion
- 24 Jan 2023 (actual)
- First posted
- 2 Feb 2023 (actual)
- 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.
In this prospective validation study, researchers investigates accuracy of EHMRG (Emergency Heart Failure Mortality Risk Grade) score in predicting the 7th and 30th day risk of mortality in patients with acute heart failure who applying to the emergency department.
Detailed description
Heart failure is a serious public health problem in the world due to its high morbidity and mortality rate.Turkish Society of Cardiology conducted a prevalence study. The name of the study is HAPPY. Accordingly, the prevalence of heart failure in people over 35 years of age in Turkey is 2.9%.The prevalence of heart failure in Turkey is higher than in European countries.
The incidence of heart failure cases with no obvious symptoms is 4.9% in Turkey. Patients with a diagnosis of heart failure apply to the emergency department frequently. There are scoring studies around the world for patients' hospitalization and discharge.
EHMRG score created and validated by Douglas S. Lee et al. In our study, the accuracy of EHMRG score will be investigated prospectively in patients diagnosed with acute heart failure in the emergency department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with acute heart failure in the emergency department | – | Other: Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failurePatients with acute heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with acute heart failure in the emergency department.
Key inclusion criteria (1 listed)
- Patients diagnosed with acute heart failure in the emergency department
Key exclusion criteria (3 listed)
- Dialysis dependent patients
- Pregnant patients
- Patients brought to the emergency department with cardiac arrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failureProspective validation of the EHMRG score in patients with acute heart failure in the emergency department | Other | Patients diagnosed with acute heart failure in the emergency department |
Primary outcome
Mortality
Time frame: 7 days
Death within 7 days after emergency department presentation for acute heart failure.
Mortality
Time frame: 30 days
Death within 30 days after emergency department presentation for acute 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 2 Feb 2023.
- Results publication: PubMed 27823694Lee DS, Lee JS, Schull MJ, Grimshaw JM, Austin PC, Tu JV. Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study. Am Heart J. 2016 Nov;181:60-65. doi: 10.1016/j.ahj.2016.07.016. Epub 2016 Aug 7.
- Results publication: PubMed 35277803van Hattem NE, Beeres SLMA, Mertens BJA, Antoni ML, Atsma DE, Schalij MJ, den Haan MC. Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions. Neth Heart J. 2022 Sep;30(9):431-435. doi: 10.1007/s12471-022-01661-3. Epub 2022 Mar 11.
- Results publication: 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.
- Results publication: PubMed 22665814Lee DS, Stitt A, Austin PC, Stukel TA, Schull MJ, Chong A, Newton GE, Lee JS, Tu JV. Prediction of heart failure mortality in emergent care: a cohort study. Ann Intern Med. 2012 Jun 5;156(11):767-75, W-261, W-262. doi: 10.7326/0003-4819-156-11-201206050-00003.
- Derived from this study: PubMed 41942909Unlu B, Demir O, Ozpolat C, Altunbas E, Denizbasi A. External prognostic validation of the EHMRG score for risk stratification and disposition decisions in acute heart failure. BMC Emerg Med. 2026 Apr 6;26(1):145. doi: 10.1186/s12873-026-01573-0.
- Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study.Link provided by the sponsor.
- Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions.Link provided by the sponsor.
- Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure.Link provided by the sponsor.
- Prediction of heart failure mortality in emergent care: a cohort study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study plan, collected data and statistical analyzes will be shared with the researchers.
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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.
Berkay UNLU, MD principal investigator
Marmara University School of Medicine Emergency Department
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 and Heart Diseases, run by Marmara University Pendik Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 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 2 Feb 2023. 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 Turkey (Türkiye). 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 NCT05710302, which also lists 5 linked publications.
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 2 Feb 2023.