NCT05632263

Brief Summary

External validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

November 19, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

7 months

First QC Date

November 19, 2022

Last Update Submit

March 13, 2023

Conditions

Keywords

EHMRGscoreACUTE HEART FAILURE

Outcome Measures

Primary Outcomes (1)

  • EHMRGscore

    The primary outcome of interest is the EHMRG predictive accuracy to prognosticate 7-day mortality was measured by the athe area under the receiver operating characteristic curver (AUROC) with 95% confidence intervals.

    7days

Secondary Outcomes (2)

  • Re-admission rate 30-day re-admission rate

    30days

  • Mortality rate Mortality rate at 30 days

    30day

Study Arms (1)

EHMRGscore

validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

Diagnostic Test: EHMRGscore

Interventions

EHMRGscoreDIAGNOSTIC_TEST

validation of the EHMRG score for hospitalized patients with acute heart failure in the emergency department

EHMRGscore

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

It is a prospective cohort study carried out in the ED of Monastir over a period from February 2009 to September 2020 which included patients admitted to the ED with a discharge diagnosis of AHF.

You may qualify if:

  • Patients consulted for acute dyspnea and were diagnosed with acute heart failure.
  • Major patient.
  • Subject who accept to participate in the research.

You may not qualify if:

  • Patient who refuse to participate in the study.
  • Impossibility of giving the patient informed information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EmergenciesHeart Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiovascular Diseases

Study Officials

  • Nouira Semir, Pr

    University of Monastir

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nouira semir, Pr

CONTACT

Bel Hadj Ali khaoula, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
clinical proffesor

Study Record Dates

First Submitted

November 19, 2022

First Posted

November 30, 2022

Study Start

April 30, 2023

Primary Completion

November 30, 2023

Study Completion

December 15, 2023

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

The EHMRG Risk score is based on commonly available parameters at presentation. It includes 10 predictors of mortality: age/mode of ED presentation / SBP / heart-rate / oxygen saturation/potassium concentration, creatinine concentration, troponin, presence of active cancer, and treatment with metolazone.