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- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Eslam M Mahran, Resident Chest Physician
- Numéro de téléphone: +201004668567
- E-mail: eslammohamedelsaeed737@gmail.com
Lieux d'étude
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Asyut Governorate
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Asyut, Asyut Governorate, Egypte, 71515
- Assuit university
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Contact:
- Eslam M Mahran, Resident Chest Physician
- Numéro de téléphone: +201004668567
- E-mail: eslammohamedelsaeed737@gmail.com
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Contact:
- Ashraf Z Mohamed, Professor
- Numéro de téléphone: +201006592600
- E-mail: ashrafabdin@yahoo.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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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
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Echocardiography assessment with focus on pulmonary artery parameters, specially Pulmonary artery systolic pressure and tricuspid valve annular Plane Systolic Excursion
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in TAPSE/PASP ratio between the acute exacerbation phase and the stable state (6-8 weeks after recovery)
Délai: 8 weeks
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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)
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8 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Ashraf Z Mohamed, Professor, Assiut University
- Directeur d'études: Lamiaa H Shaaban, Professor, Assiut University
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies vasculaires
- Maladies cardiovasculaires
- Processus pathologiques
- Maladie chronique
- Attributs de la maladie
- Maladies des voies respiratoires
- Maladies pulmonaires
- Maladies pulmonaires obstructives
- Hypertension
- Conditions pathologiques, signes et symptômes
- Maladie pulmonaire obstructive chronique
- Hypertension pulmonaire
Autres numéros d'identification d'étude
- Eslam-TAPSE/PASP ratio
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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