Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases

Recruiting

• Conditions: Connective Tissue Disease; Pulmonary Hypertension

• Registration Number: NCT01387035
• Lead Sponsor: Heidelberg University

Brief Summary

The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-07-01
• Study First Posted: 2011-07-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-12
• Last Update Posted: 2022-07-14
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• consent form
• men and women> 18 years
• fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)

Exclusion Criteria

• all contraindications for exercise testing
• significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months
• patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients	3 years	Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease?

Secondary Outcome Measures

Name	Time	Method
Subdivision of patients with connective tissue disease in different degrees of severity	3 years	Can spiroergometric findings help to subdivide patients with connective tissue diseases into groups according to degrees of severity, and differ the patients based on spiroergometric findings? To what extent is this distinction comparable with the classifications for the "functional classes" (application for PH according to the New York Heart Association (NYHA) classification)

Trial Locations

Locations (1)

Center for pulmonary Hypertension, Thoraxclinic Heidelberg; 🇩🇪 Heidelberg, Germany