Early Detection of Pulmonary- and Pulmonary Vascular Disease in Patients Suffering From Sjögren Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- prevalence of pulmonary hypertension in Sjögren syndrome
研究概览
简要总结
According to the literature available pulmonary hypertension is present in 12 to 23% of patients suffering from Sjögren Syndrome. However epidemiological data are based on non-invasive measurements using echocardiography. Furthermore, no data are available regarding exercise hemodynamics in those patients.
This study investigates pulmonary hemodynamics at rest and during exercise in patients suffering from primary and secondary Sjögren Syndrome. Patients under suspicion for pulmonary hypertension (PH) will be offered further investigations including right heart catheterization.
详细描述
Patients with primary and secondary Sjögren Syndrome will be investigated using echocardiography, exercise echocardiography, pulmonary function testing, laboratory testing, electrocardiogram and 6 minute walking test. Those patients under clinical suspicion for pulmonary hypertension will be offered further investigations including right heart catheterization to rule out or verify the diagnosis of manifest pulmonary hypertension.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •informed Consent
- •diagnosis of Sjögren Syndrome
- •age: 18 - 90 yrs
排除标准
- •uncontrolled systemic hypertension (at rest >150 mmHg systolic or 95 mmHg diastolic)
- •relevant systolic (EF<50%) or diastolic (>Grade 1) left ventricular dysfunction
- •uncontrolled ventricular arrhythmias
- •uncontrolled supraventricular bradycardia or tachycardia
- •myocardial infarction within the last 12 months
- •pulmonary embolism within the last 6 months
- •larger surgical interventions within the last 12 months
- •musculoskeletal or vascular disease, that may affect ergometric investigations
- •pregnancy (anamnesis)
结局指标
主要结局
prevalence of pulmonary hypertension in Sjögren syndrome
时间窗: 2 hours
% of patients with mean pulmonary arterial pressure \> 25 mmHg
次要结局
- forced vital capacity(2 hours)
- systolic pulmonary arterial pressure at 50 Watts(2 hours)