A Prospective Multicenter Study to Assess the Correlation of LONGterm Wrist ACTigraphy Recorded Physical Performance and 6-minute Walk Distance in Patients With Pulmonary Arterial Hypertension Newly Initiating Endothelin Receptor Antagonist Therapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
研究概览
简要总结
The objective of the study is to monitor physical activity longitudinally with a wrist activity tracker specifically in PAH patients newly initiating ERA therapy and to assess the correlation with the 6MWD at different time points. Further objectives are to assess the correlation of physical activity measured with the tracker and other parameters for clinical evaluation and right ventricular function assessment (i.e. Biomarkers, WHO Functional class, hospitalization due to PAH, Echochardiography and Quality of Life) as well as sleep efficacy in PAH patients newly initiating ERA therapy.
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
- •Male or female patients with right heart catheter (RHC)-confirmed PAH (WHO PH group I)
- •Age ≥18 year
- •Not receiving ERA therapy in the 30 days prior to the enrolment visit
- •Signed patient informed consent form
排除标准
- •Patient with conditions that prevent compliance with the protocol or to adhere to therapy and use of the device
结局指标
主要结局
Activity score measured with an electronic activity tracker and absolute 6MWD assessed at different time points during ERA treatment
时间窗: Baseline to Week 54
Change of physical activity measured with an electronic activity tracker and 6MWD in PAH patients newly initiating ERA therapy between visit 0 and end of observation
时间窗: baseline to week 54
次要结局
- WHO Functional Class(Baseline to Week 54)
- Number of hospitalization due to PAH (min. overnight)(Baseline to Week 54)
- Quality of Life(Baseline to Week 54)
- NT-ProBNP/BNP(Baseline to Week 54)
- Echocardiography parameters(Baseline to Week 54)