NCT03717779

Brief Summary

This study assesses the potential of lung ultrasonography to diagnose heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

January 2, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

July 6, 2018

Last Update Submit

January 15, 2019

Conditions

Keywords

Lung ultrasound,heart failurediagnosisaccuracy

Outcome Measures

Primary Outcomes (1)

  • the accuracy of LUS in the diagnosis of heart failure

    the accuracy of LUS in the diagnosis of heart failure measured by sensitivity ,specificity, and area under the roc curve

    0 days

Study Arms (2)

HF/HFpEF

patients with heart failure with a preserved ejection fraction(HFpEF) perform LUS

Diagnostic Test: lung ultrasound

HF/HFrEF

patients with heart failure with a reduced ejection fraction(HFrEF) perform LUS

Diagnostic Test: lung ultrasound

Interventions

lung ultrasoundDIAGNOSTIC_TEST

we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis

HF/HFpEFHF/HFrEF

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients admitted to the ED with acute dyspnea, with the final diagnosis of heart failure by the ICU team

You may qualify if:

  • non traumatic dyspnea with the final diagnosis of heart failure

You may not qualify if:

  • coma,
  • shock,Mechanical Ventilation,
  • vasopressor drugs
  • arrhythmia serious and sustained,
  • non consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency department of university hospital Fattouma Bourguiba of Monastir

Monastir, 5000, Tunisia

Location

Related Publications (1)

  • Msolli MA, Sekma A, Marzouk MB, Chaabane W, Bel Haj Ali K, Boukadida L, Bzeouich N, Gannoun I, Trabelssi I, Laaouiti K, Grissa MH, Beltaief K, Dridi Z, Belguith A, Methamem M, Bouida W, Boukef R, Boubaker H, Nouira S; GREAT Network. Bedside lung ultrasonography by emergency department residents as an aid for identifying heart failure in patients with acute dyspnea after a 2-h training course. Ultrasound J. 2021 Feb 9;13(1):5. doi: 10.1186/s13089-021-00207-9.

Related Links

MeSH Terms

Conditions

DyspneaHeart FailureDisease

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart DiseasesCardiovascular DiseasesPathologic Processes

Study Officials

  • Nouira Semir, PHD

    University hospital of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pr. Semir Nouira

Study Record Dates

First Submitted

July 6, 2018

First Posted

October 24, 2018

Study Start

January 2, 2016

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

January 16, 2019

Record last verified: 2019-01

Locations