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

NCT05366400 | Completed

• 1 other identifier: RAVI in COPD patients
• Study Type: observational
• Target: 151
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD; Right Heart Failure

Keywords

Chronic obstructive lung disease.; Right atrial volume index.; Functional capacity.; Adiponectin.; Hs-CRP.; IL1b.; Neoptrin.

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

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

Interventions

ECHO DIAGNOSTIC_TEST

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 I (CAT) ≥ 10; Group II (CAT) < 10

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Damanhour University: lead
• Tanta University: collaborator

Study Sites (1)

Tanta University Hospital

Tanta, Elgarbia, 31527, Egypt

Location

Related Publications (2)

• 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.

  PMID: 20346316 BACKGROUND

• 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.

  PMID: 9768716 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Rehab H Werida, Ass. Prof.

  Damanhour University

  PRINCIPAL INVESTIGATOR

• Lamiaa Khedr, Ass. Prof.

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 9, 2022
• Study Start: January 19, 2022
• Primary Completion: August 30, 2022
• Study Completion: September 1, 2022
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)