Relationship Between Right Atrial Volume Index, Functional Capacity and Inflammatory Biomarkers in Patients With COPD.

Completed

• Conditions: Right Heart Failure; COPD
• Interventions: Diagnostic Test: ECHO

• Registration Number: NCT05366400
• Lead Sponsor: Damanhour University

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.

Study Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2022-05-04
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group II (CAT) < 10	ECHO	CAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score \< 10 is associated with a significantly preserved health status.
Group I (CAT) ≥ 10	ECHO	CAT is an eight-item questionnaire with a six-item Likert scale ranging from 0 to 5. The score ranges from zero (completely asymptomatic) to 40 (extremely symptomatic). A CAT score ≥10 is associated with a significantly impaired health status.

Primary Outcome Measures

Name	Time	Method
RAVI (ml/m2)	3 month	Right atrial volume index
Adiponectin (mg/L)	3 month	Serum Level
Neopterin (nmol/L)	3 month	Serum Level
IL-1beta (pg/mL)	3 month	Serum Level

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Elgarbia, Egypt