Evaluating screening methods for pulmonary hypertension in scleroderma patients
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
Heidelberg University · NCT01387035
This study is testing different ways to check for pulmonary hypertension in people with scleroderma to see how well they work and how many new cases develop over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heidelberg University (other) |
| Locations | 1 site (Heidelberg) |
| Trial ID | NCT01387035 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess various screening methods to predict and confirm pulmonary hypertension (PH) in patients with scleroderma, a type of inflammatory rheumatic connective tissue disease. Additionally, it seeks to determine the incidence of new PH cases among these patients over a specified period. By focusing on a specific patient population, the study will gather valuable data that could enhance early diagnosis and management of PH in this group. The methodology includes evaluating the effectiveness of different screening techniques in identifying PH.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women over 18 years old who have a confirmed diagnosis of a collagen vascular disease.
Not a fit: Patients with significant heart conditions, other lung diseases, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and better management of pulmonary hypertension in patients with scleroderma.
How similar studies have performed: While there have been studies on pulmonary hypertension in various contexts, this specific approach focusing on scleroderma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Heidelberg
- Center for pulmonary Hypertension, Thoraxclinic Heidelberg — Heidelberg, Germany (RECRUITING)
Study contacts
- Study coordinator: Ekkehard Grünig, MD, Prof.
- Email: ekkehard.gruenig@med.uni-heidelberg.de
- Phone: +49 6221 396 8053
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Connective Tissue Disease, Pulmonary Hypertension