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

COPD Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366400
• Other study ID #: RAVI in COPD patients
• Status: Completed
• Start date: January 19, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: May 2023
• Source: Damanhour University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 1, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive
• Right Heart Failure

Intervention

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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Elgarbia

Sponsors (2)

Lead Sponsor	Collaborator
Damanhour University	Tanta University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RAVI (ml/m2)	Right atrial volume index	3 month
Primary	Adiponectin (mg/L)	Serum Level	3 month
Primary	Neopterin (nmol/L)	Serum Level	3 month
Primary	IL-1beta (pg/mL)	Serum Level	3 month