NCT06539962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 2, 2024

Last Update Submit

August 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • percentage of patients with IPF who develop cardiovascular comorbidities

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

    6 months

Secondary Outcomes (1)

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

    6 months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients diagnosed as Interstitial pulmonary fibrosis

You may not qualify if:

  • Patients refusing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Assiut University

Asyut, 711111, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 27195188BACKGROUND
  • 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.

    PMID: 20199856BACKGROUND
  • 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.

    PMID: 34200784BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Waleed MD Gamal Elddin Khaleel, Ass. Prof.

    Assiut University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Chest Diseases

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

October 1, 2024

Last Updated

August 28, 2025

Record last verified: 2025-08

Locations