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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01387035
Enrollment
50
Registered
2011-07-04
Start date
2010-01-31
Completion date
2025-12-31
Last updated
2022-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Connective Tissue Disease, Pulmonary Hypertension

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.

Interventions

None listed

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients3 yearsCorrelate 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

MeasureTime frameDescription
Subdivision of patients with connective tissue disease in different degrees of severity3 yearsCan 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)

Countries

Germany

Contacts

Primary ContactEkkehard Grünig, MD, Prof.
ekkehard.gruenig@med.uni-heidelberg.de+49 6221 396 8053

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026