COPD Exacerbation (AECOPD)NCT07694713
Dynamic Changes in Right Ventricle and Pulmonary Artery Coupling Among COPD Patients With Acute Exacerbation
An observational study of COPD Exacerbation (AECOPD) and Pulmonary Hypertension, run by Assiut University at 1 site in Egypt.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and manageable disease characterized by persistent respiratory symptoms and airflow limitation. Acute exacerbations of COPD (AECOPD) are major events in the course of the disease and are associated with increased hospital admissions, accelerated… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation (AECOPD), Pulmonary Hypertension
- What is being tested?
- Echocardiography assessment
- How many people
- 115 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged more than 40 years diagnosed with COPD based on pulmonary function tests and admitted to ICU with severe AECOPD. Severe exacerbation is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days.
Who may be able to join
- Patients aged more than 40 years diagnosed with COPD based on pulmonary function tests and admitted to ICU with severe AECOPD. Severe exacerbation is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days.
Who cannot join
- Presence of moderate to severe aortic, mitral, tricuspid, or pulmonary valvular disease
- A known history of left-sided heart failure before enrolment
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assuit University
Asyut, Asyut Governorate, 71515
Eslam M Mahran, Resident Chest Physician, +201004668567, eslammohamedelsaeed737@gmail.com
Ashraf Z Mohamed, Professor, +201006592600, ashrafabdin@yahoo.com
About this study
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and manageable disease characterized by persistent respiratory symptoms and airflow limitation. Acute exacerbations of COPD (AECOPD) are major events in the course of the disease and are associated with increased hospital admissions, accelerated decline in lung function, impaired quality of life, and increased mortality. Assessment of exacerbation risk remains a key component of COPD management according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Beyond its respiratory manifestations, COPD may have important cardiovascular consequences. Chronic hypoxia, pulmonary vascular remodeling, inflammation, and increased pulmonary vascular resistance may contribute to elevated pulmonary artery pressures and right ventricular (RV) dysfunction. Pulmonary hypertension associated with chronic lung disease is clinically important because it may worsen symptoms, exercise tolerance, and prognosis.
During acute exacerbations, worsening hypoxemia, hypercapnia, dynamic hyperinflation, and increased respiratory workload may further increase pulmonary vascular resistance and RV afterload. Transthoracic echocardiography provides a practical non-invasive method for evaluating right ventricular function and pulmonary hemodynamics through parameters such as tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), and the TAPSE/PASP ratio, a recognized marker of RV-pulmonary artery coupling.
Read the detailed description
Previous studies have demonstrated an association between COPD exacerbations and pulmonary vascular involvement. Medrek et al. reported a higher prevalence of pulmonary hypertension among patients hospitalized for COPD exacerbations compared with non-hospitalized COPD patients. More recently, studies showed that pulmonary pressures increase significantly during AECOPD compared with the stable state and are associated with prolonged hospitalization and poorer clinical outcomes.
Despite these findings, the effect of acute hypercapnic COPD exacerbations on right ventricular function, pulmonary artery pressures, and RV-pulmonary artery coupling remains incompletely understood, particularly in critically ill patients requiring ICU admission. Therefore, this study aims to evaluate the dynamic changes in right ventricular function and pulmonary artery pressures during acute hypercapnic COPD exacerbations and explore their relationship with clinical outcomes among patients admitted to the ICU.
the study aims to evaluate the dynamic changes in right ventricular-pulmonary artery coupling (TAPSE/PASP ratio) and pulmonary artery pressures during acute hypercapnic COPD exacerbations and their relationship with clinical outcomes among ICU patients.
- Conditions
- COPD Exacerbation (AECOPD), Pulmonary Hypertension
- Being tested
- Echocardiography assessment
- Keywords
- COPD, TAPSE, PASP
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiography assessmentDiagnostic test
Echocardiography assessment with focus on pulmonary artery parameters, specially Pulmonary artery systolic pressure and tricuspid valve annular Plane Systolic Excursion
| Study group | Role | What they receive |
|---|---|---|
| COPD Acute exacerbation | COPD patients with Severe exacerbation which is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days Receives: Diagnostic Test: Echocardiography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in TAPSE/PASP ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery)
Change in Tricuspid Annular Plane Systolic Excursion/Pulmonary Artery Systolic Pressure ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD Exacerbation (AECOPD)Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eslam Mohamed elsaeed Mahran Ali, Assiut University
- Investigators
- Ashraf Z Mohamed, Professor, Study director, Assiut UniversityLamiaa H Shaaban, Professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694713
- Sponsor's protocol ID
- Eslam-TAPSE/PASP ratio
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rastoder E, Sivapalan P, Hedsund C, Kamstrup P, Biering-Sorensen T, Dons M, Bistrup Petersen TC, Davidovski FS, Skaarup KG, Sengelov M, Durukan E, Vesterlev D, Wodschow HZ, Pedersen L, Eklof J, Vognsen AK, Moberg M, Janner J, Toennesen LL, Bahrami HSZ, Dixen U, Dahlgaard Hove J, Jensen MT, Ackermann DA, Jordan A, Romer V, Sperling S, Bendstrup E, Falster C, Laursen CB, Carlsen J, Jensen JS. Pulmonary pressure increases during acute exacerbation in COPD and clinical outcome. Eur Respir J. 2025 Sep 25;66(3):2500169. doi: 10.1183/13993003.00169-2025. Print 2025 Sep.
PubMed 40774812Medrek SK, Sharafkhaneh A, Spiegelman AM, Kak A, Pandit LM. Admission for COPD Exacerbation Is Associated with the Clinical Diagnosis of Pulmonary Hypertension: Results from a Retrospective Longitudinal Study of a Veteran Population. COPD. 2017 Oct;14(5):484-489. doi: 10.1080/15412555.2017.1336209. Epub 2017 Jul 17.
PubMed 28715281Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
PubMed 25559473
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Right Ventricle and Pulmonary Artery Coupling Among COPD Patients With Acute Exacerbation
- ClinicalTrials.gov ID
- NCT07694713
- Acronym / sponsor ID
- Eslam-TAPSE/PASP ratio
- Conditions
- COPD Exacerbation (AECOPD), Pulmonary Hypertension
- Keywords
- COPD, TAPSE, PASP
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 10 Jul 2026 (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.
Chronic obstructive pulmonary disease (COPD) is a common, preventable, and manageable disease characterized by persistent respiratory symptoms and airflow limitation. Acute exacerbations of COPD (AECOPD) are major events in the course of the disease and are associated with increased hospital admissions, accelerated decline in lung function, impaired quality of life, and increased mortality. Assessment of exacerbation risk remains a key component of COPD management according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).
Beyond its respiratory manifestations, COPD may have important cardiovascular consequences. Chronic hypoxia, pulmonary vascular remodeling, inflammation, and increased pulmonary vascular resistance may contribute to elevated pulmonary artery pressures and right ventricular (RV) dysfunction. Pulmonary hypertension associated with chronic lung disease is clinically important because it may worsen symptoms, exercise tolerance, and prognosis.
During acute exacerbations, worsening hypoxemia, hypercapnia, dynamic hyperinflation, and increased respiratory workload may further increase pulmonary vascular resistance and RV afterload. Transthoracic echocardiography provides a practical non-invasive method for evaluating right ventricular function and pulmonary hemodynamics through parameters such as tricuspid annular plane systolic excursion (TAPSE), pulmonary artery systolic pressure (PASP), and the TAPSE/PASP ratio, a recognized marker of RV-pulmonary artery coupling.
Detailed description
Previous studies have demonstrated an association between COPD exacerbations and pulmonary vascular involvement. Medrek et al. reported a higher prevalence of pulmonary hypertension among patients hospitalized for COPD exacerbations compared with non-hospitalized COPD patients. More recently, studies showed that pulmonary pressures increase significantly during AECOPD compared with the stable state and are associated with prolonged hospitalization and poorer clinical outcomes.
Despite these findings, the effect of acute hypercapnic COPD exacerbations on right ventricular function, pulmonary artery pressures, and RV-pulmonary artery coupling remains incompletely understood, particularly in critically ill patients requiring ICU admission. Therefore, this study aims to evaluate the dynamic changes in right ventricular function and pulmonary artery pressures during acute hypercapnic COPD exacerbations and explore their relationship with clinical outcomes among patients admitted to the ICU.
the study aims to evaluate the dynamic changes in right ventricular-pulmonary artery coupling (TAPSE/PASP ratio) and pulmonary artery pressures during acute hypercapnic COPD exacerbations and their relationship with clinical outcomes among ICU patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Acute exacerbation | – | Diagnostic Test: Echocardiography assessmentCOPD patients with Severe exacerbation which is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged more than 40 years diagnosed with COPD based on pulmonary function tests and admitted to ICU with severe AECOPD. Severe exacerbation is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days.
Key inclusion criteria (1 listed)
- Patients aged more than 40 years diagnosed with COPD based on pulmonary function tests and admitted to ICU with severe AECOPD. Severe exacerbation is defined according to GOLD 2024 as an exacerbation requiring hospitalization or an emergency department visit, in addition to the acute worsening of respiratory symptoms occurring within ≤14 days.
Key exclusion criteria (3 listed)
- Presence of moderate to severe aortic, mitral, tricuspid, or pulmonary valvular disease
- A known history of left-sided heart failure before enrolment
- refusal 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 |
|---|---|---|
| Echocardiography assessmentEchocardiography assessment with focus on pulmonary artery parameters, specially Pulmonary artery systolic pressure and tricuspid valve annular Plane Systolic Excursion | Diagnostic test | COPD Acute exacerbation |
Primary outcome
Change in TAPSE/PASP ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery)
Time frame: 8 weeks
Change in Tricuspid Annular Plane Systolic Excursion/Pulmonary Artery Systolic Pressure ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 40774812Rastoder E, Sivapalan P, Hedsund C, Kamstrup P, Biering-Sorensen T, Dons M, Bistrup Petersen TC, Davidovski FS, Skaarup KG, Sengelov M, Durukan E, Vesterlev D, Wodschow HZ, Pedersen L, Eklof J, Vognsen AK, Moberg M, Janner J, Toennesen LL, Bahrami HSZ, Dixen U, Dahlgaard Hove J, Jensen MT, Ackermann DA, Jordan A, Romer V, Sperling S, Bendstrup E, Falster C, Laursen CB, Carlsen J, Jensen JS. Pulmonary pressure increases during acute exacerbation in COPD and clinical outcome. Eur Respir J. 2025 Sep 25;66(3):2500169. doi: 10.1183/13993003.00169-2025. Print 2025 Sep.
- Background: PubMed 28715281Medrek SK, Sharafkhaneh A, Spiegelman AM, Kak A, Pandit LM. Admission for COPD Exacerbation Is Associated with the Clinical Diagnosis of Pulmonary Hypertension: Results from a Retrospective Longitudinal Study of a Veteran Population. COPD. 2017 Oct;14(5):484-489. doi: 10.1080/15412555.2017.1336209. Epub 2017 Jul 17.
- Background: PubMed 25559473Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
- Individual participant dataSharing planned: No
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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.
Ashraf Z Mohamed, Professor study director
Assiut University
Lamiaa H Shaaban, Professor study director
Assiut 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 COPD Exacerbation (AECOPD) and Pulmonary Hypertension, run by Assiut University at 1 site in Egypt.
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 3 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: opening soon, as of the sponsor's last update on 10 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eslam M Mahran, Resident chest physician (+201004668567, eslammohamedelsaeed737@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TAPSE/PASP ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery) (time frame: 8 weeks). 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 NCT07694713, which also lists 3 linked publications.
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 10 Jul 2026.