NCT01389271已完成不适用
Open-label, Uncontrolled, Prospective Long-term Observation of Inhaled Iloprost in the Treatment of Patients With Pulmonary Hypertension up to 4 Years
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
- 118
- 主要终点
- 6 Minutes walking distance (change in meters)
研究概览
简要总结
This is an open-label, uncontrolled, prospective long-term observation of Specific Drug in the treatment of patients with pulmonary hypertension up to 4 years. 160 patients with primary (idiopathic and familial) pulmonary hypertension (PH) or pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV planned to enroll. Efficacy, safety and tolerability of the drug and the survival of the patients will be observed.
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 who has pulmonary hypertension treated with inhaled iloprost older than 18 years old.
- •Primary (idiopathic and familial) pulmonary hypertension (PH) with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- •Pulmonary arterial hypertension (PAH) due to scleroderma with New York Heart Association (NYHA) functional class and exercise capacity, defined as class III and IV.
- •Patients who signed written informed consent.
排除标准
- •Severe coronary heart disease or unstable angina; Myocardial infarction within the last six months; Decompensated cardiac failure if not under close medical supervision;
- •Severe arrhythmias;
- •Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
- •Pulmonary hypertension due to venous occlusive disease.
- •Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension.
- •Pregnancy and lactation
- •Age below 18
研究组 & 干预措施
Group 1
干预措施: Ventavis inhaled (Iloprost, BAYQ6256) (Drug)
结局指标
主要结局
6 Minutes walking distance (change in meters)
时间窗: At month 48
Adverse events, weight, vital findings
时间窗: At month 48
次要结局
- 6 Minutes walking distance (% change)(At month 48)
- New York Heart Association Functional Class(At month 48)
- Pulmonary hypertension related hospitalization(At month 48)
- Change in drug dosage or frequency, need for PAH specific drug combination, need for drug change(At month 48)
- Heart and/or lung transplantation, mortality(At month 48)
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