NCT07694713

Brief 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 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Sep 2026

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

July 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

1.9 years

First QC Date

July 5, 2026

Last Update Submit

July 5, 2026

Conditions

Keywords

COPDTAPSEPASP

Outcome Measures

Primary Outcomes (1)

  • 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)

    8 weeks

Study Arms (1)

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

Diagnostic Test: Echocardiography assessment

Interventions

Echocardiography assessment with focus on pulmonary artery parameters, specially Pulmonary artery systolic pressure and tricuspid valve annular Plane Systolic Excursion

COPD Acute exacerbation

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuit University

Asyut, Asyut Governorate, 71515, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 40774812BACKGROUND
  • 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.

    PMID: 28715281BACKGROUND
  • 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.

    PMID: 25559473BACKGROUND

MeSH Terms

Conditions

Hypertension, PulmonaryPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ashraf Z Mohamed, Professor

    Assiut University

    STUDY DIRECTOR
  • Lamiaa H Shaaban, Professor

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Eslam M Mahran, Resident chest physician

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident physician in Chest diseases department

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 10, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations