Pulmonary Hemodynamics During Exercise - Research Network
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 32
- 主要终点
- Number of Participants who die during observation
研究概览
简要总结
The purpose of this Clinical Research Collaboration is to investigate the prognostic implications of pulmonary hemodynamics during exercise based on a large scale multi-centre approach by using retrospective and prospective analysis of hemodynamic data.
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
- •Patients (females and males; age: above 18yrs) with intermediate or high echocardiographic probability of PH and/or unexplained dyspnea, and/or associated conditions for PAH as clinical indication for RHC at rest and exercise
- •Written informed consent of participating subjects after being fully briefed (for prospective analysis)
排除标准
- •Patients with incomplete hemodynamic data at rest or exercise
- •Patients without sufficient follow-up data (information on survival / lung transplantation)
- •advanced tumour disease or other diseases with a short life expectancy, except pulmonary vascular diseases
- •advanced heart failure with pulmonary arterial wedge pressure (PAWP) > 18 mmHg at rest
- •uncontrolled systemic arterial hypertension (RR values > 160/100 mmHg at rest)
- •FEV1<50% predicted
- •TLC<60% predicted
结局指标
主要结局
Number of Participants who die during observation
时间窗: 6 years
The investigators aim to assess the prognostic relevance of pulmonary hemodynamics during exercise as assessed by right heart catheterization by using a multi-centre approach and to identify independent predictors of adverse events. Separate data sets will be analysed for the retrospective and prospective Evaluation.
Number of Participants undergoing lung Transplantation during observation
时间窗: 6 years
Occurrences of lung transplantations
次要结局
- Number of Participants being hospitalized during observation(6 years)
- Number of Participants who develop pulmonary Hypertension as assessed by right heart catheterization(6 years)
- Number of Participants with newly initiated pulmonary arterial Hypertension medication during observation(6 years)