Pulmonary Arterial Hypertension Quality Enhancement Research Initiative Extension Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 797
- 试验地点
- 76
- 主要终点
- Patients achieving guideline-recommended treatment
研究概览
简要总结
Knowledge Translation Program for the guidelines and evidence-based management of PAH patients
详细描述
To improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (defined as: 1) improvement of FC III or IV to FC II; 2) improvement of FC II to FC I; or 3) maintaining FC II or I)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 and female adults (≥ 18 years of age)
- •Documented diagnosis of PAH (all of the following): i. RHC demonstrating mPAP > 25 mm Hg and PCWP
- •≤ 15 and PVR > 3 ii. FEV 1 > 50% predicted normal iii. V/Q and/or CT scan excluding the thromboembolic etiology
- •Diagnosis of PAH < 3 years
- •Need for PAH specific treatment
- •Desire to participate and signs an informed consent
排除标准
- •Any of the criteria below:
- •Poor mental function, drug or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
- •Prior participation in this program
- •Patients with pulmonary hypertension classified as group 2 - 5 Updated Clinical Classification of Pulmonary Hypertension (5th World Symposium on PH Modified Classification of PH)
研究组 & 干预措施
Standard of care
Observational study to improve the management of PAH patients through an evidence-based approach aimed at achieving optimal WHO functional class (FC) treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi.
干预措施: observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi (Drug)
结局指标
主要结局
Patients achieving guideline-recommended treatment
时间窗: 3 years
Proportion of patients achieving guideline-recommended treatment
次要结局
- Patients achieving optimal functional class(3 years)