Pulmonary Disease Among Patients With Systemic Lupus Erythematosus

NCT06087523 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-10-17

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic
  • Pulmonary Disease

Interventions

OTHER

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.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER
  • Esbjerg Hospital - University Hospital of Southern Denmark

    collaborator OTHER
  • Vejle Hospital

    collaborator OTHER
  • Sonderborg Hospital

    collaborator OTHER_GOV
  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Anne Voss, MD, PhD · Odense University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-15
Primary Completion
2024-09-30
Completion
2026-01-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06087523 on ClinicalTrials.gov