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OpenTrials
Completed

NCT Number: NCT06539962

Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed as Interstitial pulmonary fibrosis

Exclusion criteria

  • Patients refusing to participate in the study

Treatment and study plan

Krebs von den Lungen-6 (KL-6)

Diagnostic Test

Krebs von den Lungen-6 (KL-6) will be evaluated for ability to predict cardiovascular comorbidities among IPF patients

Primary outcomes

  1. percentage of patients with IPF who develop cardiovascular comorbidities

    Time frame: 6 months

    Prevalence, clinical pattern of cardiovascular comorbidities among Interstitial pulmonary fibrosis cases

Secondary outcomes

  1. accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases

    Time frame: 6 months

    accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease; Potential Role for Systemic Biomarkers (Krebs Von Den Lungen-6 (KL-6))

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 6, 2024
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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