NCT01355380已完成不适用
The Efficacy of Inhaled Iloprost in Patients Treated Within the "Pulmonary Arterial Hypertension Therapeutic Programme".
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 55
- 主要终点
- Changes of the exercise capacity as measured by 6-minutes walking distance
研究概览
简要总结
This is a registry of patients diagnosed with pulmonary arterial hypertension, scheduled for treatment with Ventavis.
Typical clinical measures and quality of life will be prospectively followed in 12 months period.
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
- •Pulmonary arterial hypertension in WHO functional class III or IV
- •Patients newly treated with Ventavis or switched from sildenafil
排除标准
- •Retrospective documentation is not allowed
研究组 & 干预措施
Group 1
Drug (incl. Placebo)
干预措施: Inhaled iloprost (Ventavis, BAYQ6256) (Drug)
结局指标
主要结局
Changes of the exercise capacity as measured by 6-minutes walking distance
时间窗: 3, 6, 9 and 12 months vs. baseline
次要结局
- Number of patients with treatment-emergent adverse events(Up to 12 months)
- Changes of depression score over time(3, 6, 9 and 12 months vs. baseline)
- Changes of functional capacity as measured by WHO classification system(3, 6, 9 and 12 months vs. baseline)
- Changes of pulmonary haemodynamics(3, 6, 9 and 12 months vs. baseline)
- Changes of serum level of natriuretic peptide B(3, 6, 9 and 12 months vs. baseline)
- Changes of Quality of Life score(3, 6, 9 and 12 months vs. baseline)
- Changes in cardiac echo parameters(3, 6, 9 and 12 months vs. baseline)
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