Multi-marker Approach for Risk Assessment in Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- survival
研究概览
简要总结
Prospective registry including incident patients and prevalent patients which pretends to identify clinical characteristics, treatment trends in-hospital and ten years follow-up outcome through major adverse cardiovascular events (MACE) in a China population with well characterized PAH.
详细描述
baseline include: An echocardiogram to assess the size, shape, pumping action and the extent of any damage to the heart.
Lung function tests which include blowing measurements to assess gas volumes within the lungs as well as assessment of how the lungs exchange gases.
Right heart catheterisation (RHC) to diagnose PAH Optional Cardiac Magnetic Resonance tests. 6 minute walk distance (6MWD). To measure exercise capacity Electrocardiogram (ECG), a test that measures the electrical activity of the heart Blood tests
MACE include:
death heart/lung transplantation atrial septostomy hospitalization due to worsening of PAH start of new specific PAH treatment persistent decrease of >15% from baseline in 6MWD (or >30% compared with last study-related measurement) persistent worsening of World Health Organization (WHO) Functional Class (FC）
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Year 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PAH (by RHC)
排除标准
- •Refusal to participate.
结局指标
主要结局
survival
时间窗: 5 years
To recruit a cohort of group 1 PAH cases. define the death as the primary outcome
次要结局
- clinical worsening(5 years)