跳至主要内容
临床试验/NCT06703411
NCT06703411已完成4 期

Intravenous Iron Sucrose for Acute Decompensated Heart Failure Patients With Reduced Ejection Fraction and Iron Deficiency

Cheng-Hsin General Hospital1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
76
试验地点
1
主要终点
KCCQ score (quality of life)

研究概览

简要总结

Iron deficiency (ID) affects about 25% of the global population, presenting with symptoms of fatigue, weakness, and impaired cognitive function. Its prevalence is lower in developed regions, due to fortified foods, supplements, and better healthcare. In contrast, ID is more common in resource-limited countries, where diets lack iron, healthcare is less accessible, and infections like malaria and hookworm are more prevalent. In Asia, ID rates vary widely, influenced by dietary habits, socioeconomic factors, and healthcare quality.

The concurrent presence of ID and heart failure (HF) is increasingly acknowledged as a significant clinical issue, leading to a worsened prognosis and diminished quality of life for those affected. Recent research has reported a high prevalence of ID among HF patients, ranging from 30% to 50%, depending on the population studied and the diagnostic criteria used. Furthermore, ID in HF is linked with increased disease severity, higher hospitalization rates, and a greater risk of mortality. Interestingly, the prevalence of co-existing ID among HF patients does not vary between Western and Asian cohorts.

Recent clinical trials involving the supplement of ferric carboxymaltose have shown the effectiveness of intravenous iron therapy in enhancing exercise capacity, improving quality of life, and reducing HF-related hospitalizations in patients with heart failure and reduced ejection fraction (HFrEF) and ID. The European and American guidelines both recommend routine screening for ID in HFrEF patients and suggest considering iron carboxymaltose for those with ID to improve clinical outcomes.

Despite the importance of addressing ID in HF for optimizing patient care and improving prognosis, in many countries, due to the high price of iron carboxymaltose, only iron sucrose is available for intravenous iron supplementation, which is contrary to current guidelines. The efficacy and safety of intravenous iron sucrose in patients with HF and ID were demonstrated in the FERRIC-HF trial, but this study was conducted more than a decade ago. In an era marked by significant changes in HF treatment approaches, it remains unclear whether intravenous iron sucrose provides benefits to HF patients receiving current treatment. In this study, our objective is to examine the impact of intravenous iron sucrose on acutely decompensated HFrEF patients with co-existing ID, with a focus on improvements in iron profiles and quality of life. Our hypothesis suggests that, despite advancements in standard HF treatments, the additional use of intravenous iron sucrose could lead to an improved quality of life among HFrEF patients with ID.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Iron sucrose

Experimental

IV iron sucrose 200mg per visit

干预措施: Iron Sucrose IV (Drug)

Iron sucrose

Experimental

IV iron sucrose 200mg per visit

干预措施: Standard Medical Therapy (Drug)

Standard of care

Active Comparator

Standard of care (HFrEF4 pillars treatment)

干预措施: Standard Medical Therapy (Drug)

结局指标

主要结局

KCCQ score (quality of life)

时间窗: 4 weeks

KCCQ score (quality of life)

次要结局

  • Iron profiles(4 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hung-Yu Chang

Cardiologist

Cheng-Hsin General Hospital

研究点 (1)

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