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

• Sponsor: Marmara University Pendik Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05710302
• Collaborator: (none)
• Enrollment: 239
• Location: 1
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 40.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure; Heart Diseases; Acute Heart Failure	Other: Investigation of the diagnostic accuracy of EHMRG risk score in patients with acute heart failure

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

• Study Type: Observational
• Actual Enrollment: 239 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Investigation of the Diagnostic Accuracy of EHMRG Risk Score in Patients With Acute Heart Failure
• Actual Study Start Date: Jul 29, 2022
• Actual Primary Completion Date: Sep 3, 2022
• Actual Study Completion Date: Jan 24, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Mortality [7 days]

   Death within 7 days after emergency department presentation for acute heart failure.

2. Mortality [30 days]

   Death within 30 days after emergency department presentation for acute heart failure.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marmara University Pendik Training and Research Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Marmara University Pendik Training and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Design and rationale for the Acute Congestive Heart Failure Urgent Care Evaluation: The ACUTE Study.
• Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions.
• Prospective Validation of the Emergency Heart Failure Mortality Risk Grade for Acute Heart Failure.
• Prediction of heart failure mortality in emergent care: a cohort study.

Publications

None provided.

• Responsible Party: Berkay Ünlü, MD, Marmara University Pendik Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT05710302
• Other Study ID Numbers: 09.2022.742
• First Posted: Feb 2, 2023
• Last Update Posted: Feb 2, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Berkay Ünlü, MD, Marmara University Pendik Training and Research Hospital: mortality; emergency department; heart failure; hospitalization; risk assessment; discharge planning
• Additional relevant MeSH terms: Heart Failure; Heart Diseases

Study Results

No Results Posted as of Feb 2, 2023