Oral Iron Supplementation in Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Change in Zinc protoporphyrin from baseline
研究概览
简要总结
The purpose of this study is to investigate the effects of iron supplementation in patients with pulmonary arterial hypertension and iron deficiency.
详细描述
Pulmonary arterial hypertension (PAH) is a chronic disease associated with upregulation of hypoxia inducible-factor-1alpha (HIF-1alpha) and functional iron deficiency. The investigators are proposing a prospective, single-arm, open-label intervention to determine whether oral iron supplementation in patients with pulmonary arterial hypertension reduces markers of HIF activation and improve clinical parameters of disease. After the baseline visit, patients will be given ferrous sulfate tablets to take orally for 3 months. Outcome data will be collected at the baseline visit and at the end of the 3-month study period.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21 and older
- •diagnosis of idiopathic pulmonary arterial hypertension
- •iron deficiency (transferrin saturation <20% and serum ferritin < 100 ug/l)
排除标准
- •active infection, malignancy, or bleeding
- •hemochromatosis
- •chronic inflammatory or autoimmune disease
- •currently taking experimental/study medications, erythropoietin, iron supplementation, or immunosuppressants
- •allergy to iron
结局指标
主要结局
Change in Zinc protoporphyrin from baseline
时间窗: 3 months
Change in serum ferritin from baseline
时间窗: 3 months
次要结局
- Change in serum erythropoietin from baseline(3 months)
- Change in transferrin saturation from baseline(3 months)
- Change in %CD34+/133+ cells from baseline(3 months)
- Side effects of iron supplementation(3 months)
- Deaths and hospitalizations greater than 24 hours(3 months)
- Change in pulmonary arterial pressure from baseline(3 months)
- Change in six minute walk distance from baseline(3 months)
- NYHA/WHO classification(3 months)
研究者
Samar Farha, MD
Staff Pulmonologist
The Cleveland Clinic