Prospective Validation of the Emergency Heart Failure Mortality Risk Grade (EHMRG) Score in Patients With Acute Heart Failure in the Emergency Department

January 24, 2023 updated by: Berkay Ünlü, Marmara University Pendik Training and Research Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

239

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Marmara University Pendik Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients diagnosed with acute heart failure in the emergency department.

Description

Inclusion Criteria:

  • Patients diagnosed with acute heart failure in the emergency department

Exclusion Criteria:

  • Dialysis dependent patients
  • Pregnant patients
  • Patients brought to the emergency department with cardiac arrest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with acute heart failure in the emergency department
Patients with acute heart failure.
Other: Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure
Prospective validation of the EHMRG score in patients with acute heart failure in the emergency department

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 7 days
Death within 7 days after emergency department presentation for acute heart failure.
7 days
Mortality
Time Frame: 30 days
Death within 30 days after emergency department presentation for acute heart failure.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University Pendik Training and Research Hospital

Investigators

  • Principal Investigator: Berkay UNLU, MD, Marmara University School of Medicine Emergency Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 29, 2022

Primary Completion (ACTUAL)

September 3, 2022

Study Completion (ACTUAL)

January 24, 2023

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

January 24, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2022.742

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The study plan, collected data and statistical analyzes will be shared with the researchers.

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

Ethics Committee Approval

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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