Interstitial Lung DiseaseNCT06539962
Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease
An observational study of Interstitial Lung Disease and Cardiovascular Morbidity, run by Assiut University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Cardiovascular Morbidity
- What is being tested?
- Krebs von den Lungen-6 (KL-6)
- How many people
- 134 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- Patients diagnosed as Interstitial pulmonary fibrosis
Who cannot join
- Patients refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease; Potential Role for Systemic Biomarkers (Krebs Von Den Lungen-6 (KL-6))
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.
Read the 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.
- Being tested
- Krebs von den Lungen-6 (KL-6)
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with IPF who develop cardiovascular comorbidities
Prevalence, clinical pattern of cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
Measured: 6 months
Secondary outcomes (1)
accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Gamal Elddin Khaleel, Assiut University
- Investigators
- Waleed MD Gamal Elddin Khaleel, Ass. Prof., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539962
- Sponsor's protocol ID
- WGEK72024
- Status last verified
- Aug 2025
- First submitted
- 2 Aug 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27195188Nathan 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.
PubMed 20199856Stainer 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.
PubMed 34200784
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstitial Lung Disease is a Risk Factor for Cardiovascular Disease; Potential Role for Systemic Biomarkers (Krebs Von Den Lungen-6 (KL-6))
- ClinicalTrials.gov ID
- NCT06539962
- Acronym / sponsor ID
- WGEK72024
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients diagnosed as Interstitial pulmonary fibrosis
Key exclusion criteria (1 listed)
- Patients refusing to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Krebs von den Lungen-6 (KL-6)Krebs von den Lungen-6 (KL-6) will be evaluated for ability to predict cardiovascular comorbidities among IPF patients | Diagnostic test | – |
Primary outcome
percentage of patients with IPF who develop cardiovascular comorbidities
Time frame: 6 months
Prevalence, clinical pattern of cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
1 secondary outcome
accuracy of Krebs von den Lungen-6 (KL-6) to predict cardiovascular comorbidities among Interstitial pulmonary fibrosis cases
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Background: PubMed 27195188Agrawal 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.
- Background: PubMed 20199856Nathan 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.
- Background: PubMed 34200784Stainer 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed MD Gamal Elddin Khaleel, Ass. Prof. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease and Cardiovascular Morbidity, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with IPF who develop cardiovascular comorbidities (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06539962, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2025.