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

Study Overview
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Brief Summary
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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
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Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour University. All participants agreed to take part in this clinical study and provide informed consent. 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.. Complete physical and laboratory assessment will be done for all patients. Serum samples will be collected for measuring the biomarkers. 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. 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. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. Results, conclusion, discussion and recommendations will be given.

Official Title
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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.

Conditions
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COPD, Right Heart Failure

Intervention / Treatment
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* Diagnostic Test: ECHO


Participation Criteria
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Eligibility Criteria
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Inclusion criteria - Patients included were > 18 years old of both sexes and left ventricular ejection fraction (LVEF) >55%.The following clinical and demographic parameters were recorded; age, sex, Current cigarette smoking was defined as active smoking within the past 12 months. Coronary artery disease was obtained by history or previous medical records. Exclusion criteria - Patients with diagnosis of other respiratory diseases (e.g. asthma, interstitial pulmonary fibrosis , tuberculosis or lung cancer ), ischemic heart disease, congestive heart failure, valvular heart disease and congenital heart diseases, were excluded. Other chronic diseases, such as kidney or liver failure and cancer were also excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I (CAT) ≥ 10<br>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. | Diagnostic Test: ECHO<br>* Conventional routine tests and ECHO will be assessed. Biomarkers will be measured using ELISA The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.<br>|
| Group II (CAT) < 10<br>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. | Diagnostic Test: ECHO<br>* Conventional routine tests and ECHO will be assessed. Biomarkers will be measured using ELISA The functional capacity was assessed by the COPD assessment test (CAT) questionnaire.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RAVI (ml/m2) | Right atrial volume index | 3 month | 
| Adiponectin (mg/L) | Serum Level | 3 month | 
| Neopterin (nmol/L) | Serum Level | 3 month | 
| IL-1beta (pg/mL) | Serum Level | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic obstructive lung disease., Right atrial volume index., Functional capacity., Adiponectin., Hs-CRP., IL1b., Neoptrin.