跳至主要内容
临床试验/NCT01387035
NCT01387035招募中不适用

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

Heidelberg University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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?

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. med. Ekkehard Gruenig

Prof. Dr. med. Ekkehard Grünig

Heidelberg University

研究点 (1)

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