Prostanoid Therapy in Severe Pulmonary Arterial Hypertension - Imaging Control Study, 3D Echo, MR and RHC.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- right ventricular ejection fracture
研究概览
简要总结
The aim of the study is to intensify the follow up of patients with pulmonary arterial hypertension via modern imaging guided methods in due consideration of the possibilities of three-dimensional echocardiography in order to optimize their specific therapy.
The hypothesis is that the increased use of modern imaging guided tools is essential for the follow up.
详细描述
It is not possible to perform a magnetic resonance imaging in all patients and as a result echocardiography is not only done at screening but also during the follow up. The imaging technologies made a great progress in the last few years and enable a better assessment of the haemodynamic parameters in our days.
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
- 否
入选标准
- •pulmonary arterial hypertension WHO group I who are going to start a therapy with prostanoid
- •written informed consent
- •Prostanoid naive
- •no change of the pulmonary arterial hypertension therapy within 3 weeks of inclusion into the study
排除标准
- •pregnancy and lactation period
- •Women of childbearing potential who do not use an effective and secure method for birth control
- •severe chronic kidney insufficiency (glomerular filtration rate <30), which will remain for more than 3 months
- •liver insufficiency Child C
- •life expectancy shorter than the course of the study (for example because of a malignant disease)
结局指标
主要结局
right ventricular ejection fracture
时间窗: month 12 (+/- 7 days)
right-sided heart catheterization
次要结局
- cardiac index (CI)/cardiac output (CO)(12 months (+/- 7 Days))
- pulmonary vascular resistance(12 months (+/- 7 days))
- right atrial pressure(12 month (+/- 7 days))
- mean pulmonary capillary wedge pressure(12 month (+/-7 days))
研究者
Regina Steringer-Mascherbauer
OA Dr.
Elisabethinen Hospital