Connective Tissue Diseases & Lung Manifestations

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04095351
Study type	Observational [Patient Registry]
Source	Medical University Innsbruck
Contact	Magdalena Aichner, MD
Phone	+43 512-504-83765
Email	magdalena.aichner@i-med.ac.at
Status	Recruiting
Phase
Start date	December 9, 2019
Completion date	October 1, 2034

View Details

See also
Status	Clinical Trial	Phase
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Not yet recruiting	`NCT05947682` - Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis	N/A
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Completed	`NCT01933334` - Safety and Tolerability of Pirfenidone in Patients With Systemic Sclerosis−Related Interstitial Lung Disease (SSc-ILD) (LOTUSS)	Phase 2
Completed	`NCT01468792` - Hemodynamic Changes in Connective Tissue Disease	N/A
Terminated	`NCT00848107` - Open-Label Study of Oral Treprostinil in Digital Ulcers	Phase 2
Completed	`NCT00984932` - Effect of Rosuvastatin on Systemic Sclerosis-related Pulmonary Hypertension	Phase 3
Completed	`NCT00074568` - Scleroderma Registry
Not yet recruiting	`NCT06412614` - Evaluation of Patients With Systemic Sclerosis Without Specific or Associated Autoantibodies
Terminated	`NCT00622687` - Effect of Different Iloprost Doses on Symptoms in Systemic Sclerosis	Phase 2
Recruiting	`NCT04464434` - Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis	Phase 4
Recruiting	`NCT04246528` - SPIN Self-Management Feasibility Trial With Progression to Full-scale Trial (SPIN-SELF)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Connective Tissue Diseases and Lung Manifestations — Colipris

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms