NCT05710302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

1 month

First QC Date

January 24, 2023

Last Update Submit

January 24, 2023

Conditions

Heart FailureHeart DiseasesAcute Heart Failure

Keywords

mortalityemergency departmentheart failurehospitalizationrisk assessmentdischarge planning

Outcome Measures

Primary Outcomes (2)

  • Mortality

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

    7 days

  • Mortality

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

    30 days

Study Arms (1)

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

Interventions

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

Patients diagnosed with acute heart failure in the emergency department

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with acute heart failure in the emergency department.

You may qualify if:

  • Patients diagnosed with acute heart failure in the emergency department

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 27823694RESULT

  • van 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.

    PMID: 35277803RESULT

  • 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.

    PMID: 30586748RESULT

  • Lee 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.

    PMID: 22665814RESULT

Related Links

MeSH Terms

Conditions

Heart FailureHeart DiseasesEmergencies

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Berkay UNLU, MD

    Marmara University School of Medicine Emergency Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 2, 2023

Study Start

July 29, 2022

Primary Completion

September 3, 2022

Study Completion

January 24, 2023

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
6 months
Access Criteria
Ethics Committee Approval

Locations

TU(1)