- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07694713
Dynamic Changes in Right Ventricle and Pulmonary Artery Coupling Among COPD Patients With Acute Exacerbation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Eslam M Mahran, Resident Chest Physician
- Phone Number: +201004668567
- Email: eslammohamedelsaeed737@gmail.com
Study Locations
-
-
Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71515
- Assuit University
-
Contact:
- Eslam M Mahran, Resident Chest Physician
- Phone Number: +201004668567
- Email: eslammohamedelsaeed737@gmail.com
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Contact:
- Ashraf Z Mohamed, Professor
- Phone Number: +201006592600
- Email: ashrafabdin@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
Echocardiography assessment with focus on pulmonary artery parameters, specially Pulmonary artery systolic pressure and tricuspid valve annular Plane Systolic Excursion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Ashraf Z Mohamed, Professor, Assiut University
- Study Director: Lamiaa H Shaaban, Professor, Assiut University
Publications and helpful links
General Publications
- Lang 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.
- 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.
- Medrek 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Eslam-TAPSE/PASP ratio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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