Connective Tissue Diseases and Lung Manifestations

NCT04095351 | Recruiting

• 1 other identifier: 20190506-2003
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Connective Tissue Diseases; Interstitial Lung Disease; Systemic Sclerosis

Outcome Measures

Primary Outcomes (3)

• Decline in forced vital capacity

  Absolute decline from baseline in forced vital capacity percent predicted. Lung function tests are performed by a trained professional.

  1 year

• Increase in the modified Rodnan Skin Score

  Change in the modified Rodnan Skin Score from baseline of \>5 Points assessed by a trained professional

  1 year

• Decline in Diffusion capacity for carbon monoxide

  Absolute decline from baseline in diffusion capacity for carbon monoxide in percent measured. Lung function tests are performed by a trained professional.

  1 year

Interventions

Pulmonary function test DIAGNOSTIC_TEST

Spirometry or plethysmography, measurement of diffusion capacity

Imaging DIAGNOSTIC_TEST

Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography

Blood sampling BIOLOGICAL

Standard laboratory test for CTDs as part of routine clinical examination

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Real-life cohort of CTD patients

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Medical University Innsbruck, Department of Internal Medicine II

Innsbruck, 6020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

From each patient with proven systemic sclerosis one serum vial of 10 ml and 2 EDTA vials à 10 ml will be taken. Peripheral blood mononuclear cells are isolated from the EDTA blood samples, an stored at -80°C.The serum samples will be centrifuged and the resulting serum is collected in cryovials and stored at -80 °C until measurement. Samples and data will be stored and archived central according to the new standards of the biobank facility of the medical university of Innsbruck.

MeSH Terms

Conditions

Connective Tissue Diseases; Lung Diseases, Interstitial; Scleroderma, Systemic

Interventions

Respiratory Function Tests; Diagnostic Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Lung Diseases; Respiratory Tract Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Judith Löffler-Ragg, Prof. MD

  Medical University Innsbruck, Department Internal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magdalena Aichner, MD

CONTACT

+43 512-504-83765; magdalena.aichner@i-med.ac.at

Graziella Plank

CONTACT

+43 512-504-81884; graziella.plank@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 19, 2019
• Study Start: December 9, 2019
• Primary Completion: March 1, 2021
• Study Completion (Estimated): October 1, 2034
• Last Updated: May 27, 2020

Record last verified: 2019-09

Locations

AU (1)