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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01387035
• Other study ID #: S-360/2009
• Status: Recruiting
• Start date: January 2010
• Est. completion date: December 2025

Study information

• Verified date: July 2022
• Source: Heidelberg University
• Contact: Ekkehard Grünig, MD, Prof.
• Phone: +49 6221 396 8053
• Email: ekkehard.gruenig[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Connective Tissue Disease
• Connective Tissue Diseases
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
Germany	Center for pulmonary Hypertension, Thoraxclinic Heidelberg	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients	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?	3 years
Secondary	Subdivision of patients with connective tissue disease in different degrees of severity	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)	3 years