NCT05352490

Brief Summary

Acute Heart failure (AHF) is a common cause of acute exacerbation of chronic obstructive pulmonary disease (AECOPD). This association is frequently underestimated with regard to the difficulty of clinical diagnosis. The investigators expect that the application of the lung ultrasound could be useful in this issue.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

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

March 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

July 7, 2026

Status Verified

August 1, 2022

Enrollment Period

1.2 years

First QC Date

March 9, 2022

Last Update Submit

July 5, 2026

Conditions

Keywords

COPD Acute Heart Failure Lung ultrasound

Outcome Measures

Primary Outcomes (2)

  • LUS in COPD patients whith pulmonory echography

    LUS measured whith pulmonory echography by the number of lines A and B.

    1day

  • the accuracy of LUS in the diagnosis of heart failure in COPD patients

    the accuracy of LUS in the diagnosis of heart failure in patients with COPD measured by area under the roc curve

    1day

Study Arms (2)

HF-group

patients with AECOPD and acute heart failure

Diagnostic Test: calculate LUS score

non HF-group

patients with AECOPD without acute heart failure

Diagnostic Test: calculate LUS score

Interventions

calculate LUS scoreDIAGNOSTIC_TEST

calculate LUS score

HF-groupnon HF-group

Eligibility Criteria

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

patients with history of COPD admitted to the emergency departmet for dyspnea

You may qualify if:

  • patients with history of COPD admitted to the emergency department for dyspnea non traumatic dyspnea

You may not qualify if:

  • instable hemodynamic or neurological status non consent to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Departement

Monastir, 5000, Tunisia

Location

Related Publications (1)

  • Lajili F, Toumia M, Sekma A, Bel Haj Ali K, Sassi S, Zorgati A, Yaakoubi H, Youssef R, Grissa MH, Beltaief K, Mezgar Z, Khrouf M, Chamtouri I, Bouida W, Boubaker H, Msolli MA, Dridi Z, Boukef R, Nouira S. Value of Lung Ultrasound Sonography B-Lines Quantification as a Marker of Heart Failure in COPD Exacerbation. Int J Chron Obstruct Pulmon Dis. 2024 Aug 1;19:1767-1774. doi: 10.2147/COPD.S447819. eCollection 2024.

Related Links

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nouira semir Nouira semir, professor

    Principal Investigator university

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 9, 2022

First Posted

April 28, 2022

Study Start

March 1, 2022

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

July 7, 2026

Record last verified: 2022-08

Locations