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

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.

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.

Study Overview

• Status: Completed
• Conditions: COPD; Right Heart Failure
• Intervention / Treatment: Diagnostic test: ECHO

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 Type: Observational
• Enrollment (Actual): 151

Contacts and Locations

Study Locations

• Egypt
  • Elgarbia
    • Tanta, Elgarbia, Egypt, 31527
      • tanta University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All COPD patients participate in this study, were diagnosed on clinical based data and confirmed by spirometry findings according to the diagnostic criteria of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines.

This study was carried out on COPD 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group I (CAT) ≥ 10; 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; 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.
Group II (CAT) < 10; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Damanhour University
• Collaborators: Tanta University
• Investigators: Principal Investigator: Rehab H Werida, Ass. Prof., Damanhour University; Principal Investigator: Lamiaa Khedr, Ass. Prof., Tanta University

Publications and helpful links

General Publications

• de Groote P, Millaire A, Foucher-Hossein C, Nugue O, Marchandise X, Ducloux G, Lablanche JM. Right ventricular ejection fraction is an independent predictor of survival in patients with moderate heart failure. J Am Coll Cardiol. 1998 Oct;32(4):948-54. doi: 10.1016/s0735-1097(98)00337-4.
• Thierer J, Acosta A, Vainstein N, Sultan M, Francesia A, Marino J, Prado AH, Guglielmone R, Trivi M, Boero L, Brites F, Anker S. Relation of left ventricular ejection fraction and functional capacity with metabolism and inflammation in chronic heart failure with reduced ejection fraction (from the MIMICA Study). Am J Cardiol. 2010 Apr 1;105(7):977-83. doi: 10.1016/j.amjcard.2009.11.017. Epub 2010 Feb 13.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: May 4, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 18, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Functional capacity.; Chronic obstructive lung disease.; Right atrial volume index.; Adiponectin.; Hs-CRP.; IL1b.; Neoptrin.
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RAVI in COPD patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No