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Clinical Trials/NCT01387035
NCT01387035
Recruiting
Not Applicable

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

Heidelberg University1 site in 1 country50 target enrollmentJanuary 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Connective Tissue Disease
Sponsor
Heidelberg University
Enrollment
50
Locations
1
Primary Endpoint
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
December 2025
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Heidelberg University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients

Time Frame: 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 Outcomes

  • Subdivision of patients with connective tissue disease in different degrees of severity(3 years)

Study Sites (1)

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