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Clinical Trials/NCT05366400
NCT05366400
Completed
N/A

Evaluation of the Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With Chronic Obstructive Lung Disease and Right Heart Affection.

Damanhour University1 site in 1 country151 target enrollmentJanuary 19, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
COPD
Sponsor
Damanhour University
Enrollment
151
Locations
1
Primary Endpoint
IL-1beta (pg/mL)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

Right ventricular (RV) dysfunction is associated with increased morbidity and mortality in patients with chronic obstructive pulmonary disease (COPD). Assessment of RV function by echocardiography is challenging. Easy visualization of the right atrium (RA) by echocardiography , allows quantitative, highly reproducible assessment of RA volume. The aim of the present study is to evaluate the relationship between the right atrial volume index (RAVI) and functional capacity in patients with COPD , quantified by the COPD assessment test (CAT) questionnaire as an early predictor of right heart affection.

Detailed Description

1. Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. 2. All participants agreed to take part in this clinical study and provide informed consent. 3. Patients who were selected from patients visited Chest Department or attending Chest outpatient clinic of Tanta University Hospitals, Echocardiography was done in the Cardiology Department.. 4. Complete physical and laboratory assessment will be done for all patients. 5. Serum samples will be collected for measuring the biomarkers. 6. 150 patients with COPD and preserved left ventricular systolic function, ejection fraction (LVEF) \> 55% will enrolled. The RA volume calculated by biplane area length method using four chamber view twice and indexed to body surface area (RAVI). Assessment of RV systolic function was done using tricuspid annular plane systolic excursion (TAPSE), and peak systolic velocity (S'tri) using tissue Doppler imaging at the tricuspid annulus. The functional capacity was assessed by the COPD assessment test (CAT) questionnaire. 7. For each participant, blood samples were obtained and levels of adiponectin, IL-1B, high-sensitivity C-reactive protein and Neopterin will be determined in all studied subjects. 8. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 9. Results, conclusion, discussion and recommendations will be given.

Registry
clinicaltrials.gov
Start Date
January 19, 2022
End Date
September 1, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rehab Werida

Associate Professor

Damanhour University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

IL-1beta (pg/mL)

Time Frame: 3 month

Serum Level

RAVI (ml/m2)

Time Frame: 3 month

Right atrial volume index

Adiponectin (mg/L)

Time Frame: 3 month

Serum Level

Neopterin (nmol/L)

Time Frame: 3 month

Serum Level

Study Sites (1)

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