Intravenous Iron Treatment In Iron Deficient Patients With Idiopathic Pulmonary Arterial Hypertension
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- six-minute walking distance
研究概览
简要总结
Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency were previously shown to have a decreased six-minute walking distance. Therefore the investigators hypothesized that intravenous iron administration would improve exercise capacity in iron deficient IPAH patients.
30 patients will be recruited for iron infusions. At baseline and after 12 weeks (endpoint)exercise test will be performed.
详细描述
Background: Patients with pulmonary arterial hypertension (PAH) develop progressive right heart failure which eventually will lead to death. During progression of the disease the physical performance of the patients deteriorates. Maintaining their exercise capacity is a major goal in PAH treatment. Iron treatment is known to have a positive effect on physical performance in patients with left heart failure and iron deficiency. Whether this is also effective in patients with right heart failure (PAH) and iron deficiency is until now unknown.
Objective: To evaluate the effects of intravenous iron supplementation on exercise capacity in iron deficient IPAH patients.
Study design: Intervention study
Study population: Patients with idiopathic pulmonary arterial hypertension (IPAH) and iron deficiency
Patients receive an iron bolus infusion of 1000 mg iron after baseline measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Stable idiopathic pulmonary arterial hypertension (stable disease for at least 3 months)
- •iron deficiency (serum iron below 10 μmol/l, decreased transferrin saturation (< 15% in females and < 20% in males) and serum ferritin < 100 μg/l) irrespective of the coexistence of anaemia
排除标准
- •Current iron therapy (oral or iv)
- •Current other study medication for PAH
- •History of anaemia or current treatment for anaemia
- •Liver function impairment
- •Chronic disease other than PAH (rheumatism, asthma, chronic infection)
- •Acute infection
结局指标
主要结局
six-minute walking distance
时间窗: 12 weeks
The primary endpoint is improvement in six-minute walking distance
次要结局
- Serum iron parameters(0 and 12 weeks)
- Exercise capacity(0 and 12 weeks)
- Quadriceps muscle function(0 and 12 weeks)
- Cardiac Function(0 and 12 weeks)
- Quality of life(0 and 12 weeks)