Connective Tissue Diseases and Lung Manifestations

  • STATUS
    Recruiting
  • End date
    Oct 1, 2034
  • participants needed
    120
  • sponsor
    Medical University Innsbruck
Updated on 24 January 2021
hypertension
pulmonary function test
pulmonary disease
progressive disease
lung disease
spirometry
rheumatism
diagnostic procedures
pulmonary hypertension
connective tissue disorder
interstitial lung disease
connective tissue diseases

Summary

Despite a number of prospective studies already initiated in the past years, the current epidemiology and course of interstitial lung disease (ILD) and pulmonary hypertension (PH) in patients with connective tissue disease (CTD) is still not well defined, particularly regarding its prevalence, incidence and the management of a broad spectrum of disease presentations.

Major challenges include the identification of patients with progressive disease, the appropriate time point of therapeutic intervention and the underlying driver of disease (inflammatory or pro-fibrotic stimulus or both?).

To address these issues in Western Austria, a progressive registry of patients with CTD exploring routine clinical and pathophysiological characteristics of ILD and PH will be conducted. This multidisciplinary, prospective and observational registry aims to collect comprehensive clinical data on incidence, prevalence and course of disease regarding all PH and ILD presentations in a real-world setting.

Description

Specifically, this registry will collect demographic data, disease-related clinical data, routine laboratory values (including antibody-profile and iron status), diagnostic procedures, significant comorbidities, therapeutic managements (e.g. thoracic ultrasound, HRCT), and disease outcomes over 10 years.

In addition, blood biobank samples for translational research will be collected in a subgroup of patients with systemic sclerosis over serial time points to study the systemic inflammatory and profibrotic phenotype of patients. In summary, this registry will monitor the disease course of pulmonary manifestations of patients with CTD and may be hypothesis-generating and provide new insights in underlying inflammatory/pro-fibrotic patterns.

Details
Condition Pulmonary Disease, CONNECTIVE TISSUE DISEASE, Scleroderma, Systemic sclerosis, Pulmonary Fibrosis, Dermatosis, Interstitial lung disease, Dermatomyositis (Connective Tissue Disease), Congenital Skin Diseases, Skin Conditions, Connective Tissue Diseases, Lung Disease, connective tissue disorder, interstitial lung diseases, progressive systemic sclerosis
Treatment blood sampling, Imaging, Pulmonary function test
Clinical Study IdentifierNCT04095351
SponsorMedical University Innsbruck
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

The inclusion criteria are adult patients (18 years) diagnosed with CTD with signed informed consent

Exclusion Criteria

Exclusion criteria are patients with a serious co-morbidity interfering with the course of interstitial lung disease or pulmonary hypertension
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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