Clinical trial NCT06539962: Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease
Official title: Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease; Potential Role for Systemic Biomarkers (Krebs Von Den Lungen-6 (KL-6))
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Cardiovascular Morbidity
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Demographic characteristics of patients diagnosed with interstitial pulmonary fibrosis and recruited from Assiut university hospital outpatient clinic will be recorded, including sex, age, smoking status, underlying comorbidities, addiction status.

Chest symptoms evaluation: Cough, expectoration, hemoptysis, dyspnea, wheeze and chest pain.

Comorbidity evaluation; including DM, hypertension, hepatic diseases, renal diseases.

Cardiovascular comorbidities thorough assessment including; ECG, Lipid profile and echocardiography.

chest radiograph and computed tomography (CT) chest findings will be assessed. Laboratory investigations: Lipid profile, CRP and KL-6 level according to the manufacturer's instructions

Brief summary: A group of Interstitial pulmonary fibrosis will be recruited from Assiut university hospital outpatient clinic.

Evaluation will be done regarding cardiovascular comorbidities (Cardiovascular comorbidities will be evaluated with thorough assessment including; history, ECG, Lipid profile and echocardiography).

Lipid profile, CRP and KL-6 level will be assessed for recruited personnel. Regression analysis will be used to identify risk factors for cardiovascular comorbidities among IPF patients.

Detailed description: Interstitial lung disease (ILD) is a chronic, progressive, parenchymal disease of the lungs. ILD has been associated with various cardiovascular co-morbidities, such as coronary artery disease (CAD) and heart failure (HF). So far, little is known regarding the cardiovascular co-morbidities in patients with idiopathic pulmonary fibrosis (IPF), the most aggressive form of ILD.

Blood biomarkers have been shown to emerging evidence in patients with IPF in clinical practice. Several blood biomarkers, including lung-epithelium specific proteins, chemokines, growth factors, proteases, and other serological markers, have been studied widely in the fields of diagnosis, disease severity, and prognosis in patients with IPF. Among them, Krebs von den Lungen-6 (KL-6) is used in clinical practice and elevated level of KL-6 is known to predict mortality in patients with IPF.

It is well documented that fibrosis is closely linked to the inflammatory response. Emerging evidence suggests that cardiac fibrosis in general is primarily due to complications associated with acute and prolonged inflammation, suggesting that even low-grade, persistent inflammation is enough to promote cardiac fibrosis. The cellular and molecular events that underpin the inflammatory processes in cardiac disease are complex and poorly understood, with many tissue and disease specific mechanisms.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as Interstitial pulmonary fibrosis

Exclusion Criteria:

* Patients refusing to participate in the study

Primary outcomes:
measure: percentage of patients with IPF who develop cardiovascular comorbidities
timeFrame: 6 months
Secondary outcomes:
measure: accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
timeFrame: 6 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine, Assiut University
Study officials:
affiliation: Assiut University
name: Waleed MD Gamal Elddin Khaleel, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agrawal A, Verma I, Shah V, Agarwal A, Sikachi RR. Cardiac manifestations of idiopathic pulmonary fibrosis. Intractable Rare Dis Res. 2016 May;5(2):70-5. doi: 10.5582/irdr.2016.01023.
citation: Nathan SD, Basavaraj A, Reichner C, Shlobin OA, Ahmad S, Kiernan J, Burton N, Barnett SD. Prevalence and impact of coronary artery disease in idiopathic pulmonary fibrosis. Respir Med. 2010 Jul;104(7):1035-41. doi: 10.1016/j.rmed.2010.02.008. Epub 2010 Mar 2.
citation: Stainer A, Faverio P, Busnelli S, Catalano M, Della Zoppa M, Marruchella A, Pesci A, Luppi F. Molecular Biomarkers in Idiopathic Pulmonary Fibrosis: State of the Art and Future Directions. Int J Mol Sci. 2021 Jun 10;22(12):6255. doi: 10.3390/ijms22126255.