Pulmonary Disease Among Patients With Systemic Lupus Erythematosus

NCT ID: NCT06087523

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2026-01-01

Brief Summary

Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and associated with a significantly increased morbidity, mortality, and lower self-reported health related quality of life.

The investigators aim to diagnose and categorise SLE patients in regards of pulmonary disease and introduce alternative diagnostic tools.

The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, high-resolution computed tomography of the thorax (HRCT), thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist.

The investigators believe that the study will increase the understanding of pulmonary diseases among SLE patients, which could improve overall disease management. The investigators will introduce new alternative diagnostic tools, that could ease diagnosing pulmonary disease among SLE.

Detailed Description

Background Pulmonary diseases are common among patients with Systemic Lupus Erythematosus (SLE) and cover a variety of manifestations including pleuritis and interstitial lung disease. Pulmonary diseases among SLE patients are associated with an increased morbidity, mortality, and lower self-reported health related quality of life.

Objective The primary objective of the study is to diagnose and categorise a population-based study population of SLE patients in regards of pulmonary diseases. The secondary objective of the study is to introduce alternative diagnostic tools to diagnose pulmonary disease among SLE patients, including thoracic ultrasound and circulating biomarkers.

Methods and Analysis The study will be reported according to the STROBE guidelines. The investigators will perform a cross-sectional study of a population-based study population of SLE patients. The participants will undergo review of medical record, a clinical assessment, body plethysmography, six-minute walk test, HRCT, thoracic and diaphragmatic ultrasound, blood sampling with analysis of autoantibodies, and three questionnaires translated to Danish - Saint George's Respiratory Questionnaire, Systemic Lupus Activity Questionnaire, and Lupus Impact Tracker. After the investigations, pulmonary diseases among the participants will be diagnosed at a multidisciplinary discussion by a specialised pulmonologist with contribution from a rheumatologist and a radiologist. The results will be blinded to the investigators except for Henrik Zachar Langkilde who will have access to results (except for the MDD diagnose) while the investigations are performed, and before the unblinding a statistical analyse plan will be reported. At the second of October 22 participants have had a visit.

Discussion Pulmonary diseases among SLE patients are common and of importance to the patients, but an area not studied as extensively as other disease manifestations. The investigators believe that this study will increase the understanding of pulmonary disease among SLE patients, which could improve overall disease management for the patients. The investigators hope that the alternative diagnostic tools introduced will ease to diagnose pulmonary disease among SLE patients. The study is approved by the Committees on Health Research Ethics and an umbrella organisation under the Danish Data Protection agency. The project, the protocol and the study design are discussed with two SLE patient partners, and the patient partners suggestions have been incorperated in the project.

Conditions

Lupus Erythematosus, Systemic; Pulmonary Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Interventions

Multidisciplinary discussion

Multidisciplinary discussion: Participants will be diagnosed and categorized in regards of pulmonary disease on basis of medical record, PFT, HRCT, and questionnaires.

PFT: Participants will undergo body plethysmography (with diffusion) and six-minute walk test.

Analysis of circulating biomarkers: We will store glasses with serum and glasses with plasma and analyse them for circulating biomarker.

Questionnaires: Participants will complete Danish versions of three questionnaires.

• Saint George's Respiratory Questionnaire Interstitial Pulmonary Fibrosis
• Systemic Lupus Activity Questionnaire
• Lupus Impact Tracker

Review of medical record and clinical investigation with focus on SLE and pulmonary disease.

Thoracic and diaphragmatic ultrasound: The participants will undergo a 14 zone protocol, and be evaluated for b-lines and pleural thickening/irregularities. Diaphragm function will be evaluated according to the M-mode method, area method, and for thickening.

Intervention Type: OTHER

Other Intervention Names

Thoracic and diaphragmatic ultrasound; High resolution CT scan of thorax (HRCT); Pulmonary function testing (PFT); Analysis of circulating biomarkers; Questionnaires (PROMs); Review of medical record.; Clinical investigation

Eligibility Criteria

Inclusion Criteria

• Followed at a Department of Rheumatology in Region Southern Denmark.
• Living in Region Southern Denmark.
• Diagnosed with Systemic Lupus Erythematosus.
• Fulfil the 2019 European League Against Rheumatism / American College of Rheumatology classification criteria.
• Speak and understand spoken and written Danish

Exclusion Criteria

• Participants not having their native lungs
• Not participating in visit day, without a valid reason.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: collaborator

Vejle Hospital

OTHER

Sponsor Role: collaborator

Sonderborg Hospital

OTHER_GOV

Sponsor Role: collaborator

Odense University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Anne Voss

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anne Voss, MD, PhD

Role: STUDY_CHAIR

Odense University Hospital

Locations

Odense University Hospital

Odense, Region Southern Denmark, Denmark

Countries

Denmark

Other Identifiers

OP_1858

Identifier Type: -

Identifier Source: org_study_id