DyspneaNCT05352490
Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound
An observational study of Dyspnea and Decompensated Heart Failure ; COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Decompensated Heart Failure ; COPD Exacerbation
- What is being tested?
- calculate LUS score
- How many people
- 350 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Mar 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with history of COPD admitted to the emergency departmet for dyspnea
Who may be able to join
- patients with history of COPD admitted to the emergency department for dyspnea non traumatic dyspnea
Who cannot join
- instable hemodynamic or neurological status non consent to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a frequent disease in our population affecting mainly the elderly and males. Dyspnea is the most common reason for consultation for patients with COPD in ED. Distinguishing between pulmonary and/or cardiac origin can be challenging.Physical examination, laboratory findings and radiography are imperfect. Lung ultrasound sonography (LUS) has recently gained a large place in the diagnosis of heart failure (HF), but its contribution to the diagnosis of HF in COPD remains poorly studied.
Purpose: The purpose of this study is to assess the contribution of LUS in the diagnosis of HF in COPD patients with acute dyspnea
. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management. Lung ultrasonography is becoming a standard tool in critical cases in the ED. the investigators aim to perform ultrasonography on COPD patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team. Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles. This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.This study includes patients with COPD consulting for acute dyspnea. We performed a lung ultrasound on all patients included. The diagnosis of heart failure (HF) was based on clinical, radiological, cardiac-ultrasound and expert data. The LUS diagnostic performance indicators were calculated using the different cut-off proposed by the LUS score.Then the probability of AHF was defined as : low probability (LUS<15) intermediate probability (15≤ LUS<30), and high probability (LUS≥30 ).
- Being tested
- calculate LUS score
- Keywords
- COPD Acute Heart Failure Lung ultrasound
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calculate LUS scoreDiagnostic test
calculate LUS score
| Study group | Role | What they receive |
|---|---|---|
| HF-group | patients with AECOPD and acute heart failure Receives: Diagnostic Test: calculate LUS score | |
| non HF-group | patients with AECOPD without acute heart failure Receives: Diagnostic Test: calculate LUS score |
What is being measured
The primary outcome is the main question the study is designed to answer.
LUS in COPD patients whith pulmonory echography
LUS measured whith pulmonory echography by the number of lines A and B.
Measured: 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
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Mar 2022
- Primary completion31 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyspneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira semir Nouira semir, professor, Study director, Principal Investigator university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352490
- Sponsor's protocol ID
- Lung ultrasound, COPD, HF
- Status last verified
- Aug 2022
- First submitted
- 9 Mar 2022
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39108664
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Heart Failure in Chronic Obstructive Pulmonary Disease Using the Lung Ultrasound
- ClinicalTrials.gov ID
- NCT05352490
- Acronym / sponsor ID
- Lung ultrasound, COPD, HF
- Keywords
- COPD Acute Heart Failure Lung ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a frequent disease in our population affecting mainly the elderly and males. Dyspnea is the most common reason for consultation for patients with COPD in ED. Distinguishing between pulmonary and/or cardiac origin can be challenging.Physical examination, laboratory findings and radiography are imperfect. Lung ultrasound sonography (LUS) has recently gained a large place in the diagnosis of heart failure (HF), but its contribution to the diagnosis of HF in COPD remains poorly studied.
Purpose: The purpose of this study is to assess the contribution of LUS in the diagnosis of HF in COPD patients with acute dyspnea
. Physical examination, laboratory findings and radiography are imperfect, resulting in a need for sophisticated test results that delay management. Lung ultrasonography is becoming a standard tool in critical cases in the ED. the investigators aim to perform ultrasonography on COPD patients admitted to the ICU with dyspnea, comparing lung ultrasonography results on initial presentation with the final diagnosis by the ICU team. Three items were assessed: artifacts (horizontal A lines or vertical B lines indicating interstitial syndrome), lung sliding, and alveolar consolidation and/or pleural effusion, these items were grouped to assess ultrasound profiles. This study assesses the potential of lung ultrasonography to diagnose heart failure.The second aim of this study was to evaluate the inter-observer reproducibility of LUS performed by ED residents in the evaluation of cardiac causes of acute dyspnea.This study includes patients with COPD consulting for acute dyspnea. We performed a lung ultrasound on all patients included. The diagnosis of heart failure (HF) was based on clinical, radiological, cardiac-ultrasound and expert data. The LUS diagnostic performance indicators were calculated using the different cut-off proposed by the LUS score.Then the probability of AHF was defined as : low probability (LUS<15) intermediate probability (15≤ LUS<30), and high probability (LUS≥30 ).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HF-group | – | Diagnostic Test: calculate LUS scorepatients with AECOPD and acute heart failure |
| non HF-group | – | Diagnostic Test: calculate LUS scorepatients with AECOPD without acute heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with history of COPD admitted to the emergency departmet for dyspnea
Key inclusion criteria (1 listed)
- patients with history of COPD admitted to the emergency department for dyspnea non traumatic dyspnea
Key exclusion criteria (1 listed)
- instable hemodynamic or neurological status non consent to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calculate LUS scorecalculate LUS score | Diagnostic test | HF-group, non HF-group |
Primary outcome
LUS in COPD patients whith pulmonory echography
Time frame: 1day
LUS measured whith pulmonory echography by the number of lines A and B.
the accuracy of LUS in the diagnosis of heart failure in COPD patients
Time frame: 1day
the accuracy of LUS in the diagnosis of heart failure in patients with COPD measured by area under the roc curve
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Derived from this study: PubMed 39108664Lajili 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.
- official department websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira semir Nouira semir, professor study director
Principal Investigator university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dyspnea and Decompensated Heart Failure ; COPD Exacerbation, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LUS in COPD patients whith pulmonory echography (time frame: 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.