A Prospective, Multicenter, International Non-interventional, Observational Cohort Study to Observe Long-term Treatment Patterns and Real-word Outcomes in PAH Group I Patients Previously Participating in TripleTRE - TripleTRE-NIS
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 110
- 试验地点
- 18
- 主要终点
- Time to death or lung transplantation
研究概览
简要总结
The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.
The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.
Planned observation duration per patient is a minimum of 3 years.
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 previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS
排除标准
- •Lost to follow-up patients of TripleTRE study
- •Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
- •Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)
结局指标
主要结局
Time to death or lung transplantation
时间窗: up to year 3
Time to first clinical worsening
时间窗: up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PAH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
Total number of clinical worsenings
时间窗: up to year 3
clinical worsening is defined as fulfilling on of the following criteria: * PAH related death (including all deaths where PAH cannot be excluded as cause) * Lung transplantation due to PAH * PH-related hospitalization * Post baseline decrease in 6MWD by 15% * Post baseline worsening of WHO FC
次要结局
- Long-term change in WHO FC(up to year 3)
- Long-term change in BDS(up to year 3)
- Long-term change in Cardiac Output (CO)(up to year 3)
- Long-term change in RV-PA coupling(up to year 3)
- Long-term change in RV end-systolic area (RVESA)(up to year 3)
- Long-term change in 6MWD(up to year 3)
- Long-term change in PAH treatment regimens(up to year 3)
- Long-term change in risk status(up to year 3)
- Long-term change in NT-proBNP/BNP(up to year 3)
- Long-term change in Pulmonary Vascular Resistance (PVR)(up to year 3)
- Long-term change in Stroke volume index (SVI)(up to year 3)
- Long-term change in RV end-diastolic area (RVEDA)(up to year 3)
- Long-term change in mean Pulmonary Arterial Pressure (mPAP)(up to year 3)
- Long-term change in Right Atrial Pressure (RAP)(up to year 3)
- Long-term change in mean Right Atrial Pressure (mRAP)(up to year 3)
- Long-term change in Cardiac Index (CI)(up to year 3)
- Long-term change in Pulmonary capillary wedge pressure (PCWP)(up to year 3)
- Long-term change in RV fractional area change (RVFAC)(up to year 3)
- Long-term change in Right ventricular ejection fraction (RVEF)(up to year 3)
- Long-term change in Right Atrium (RA) area(up to year 3)
- Long-term change in Pericardial effusion(up to year 3)