Effectiveness of Intravenous Iron Treatment vs Standard Care in Patients With Heart Failure and Iron Deficiency: a Randomised, Open-label Multicentre Trial (IRONMAN)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,160
- 试验地点
- 72
- 主要终点
- CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
研究概览
简要总结
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
详细描述
Chronic heart failure (CHF) is a very common medical problem. Despite improvements in treatment, many patients suffer limiting symptoms of shortness of breath and fatigue. Hospitalisation for CHF is common and life expectancy reduced. Many patients with CHF have a deficiency of iron (low iron levels or cannot use iron properly), and this is associated with poorer outcomes. Some small research studies have suggested that giving patients intravenous iron improves symptoms in the short term. It is unknown, however, whether correcting iron deficiency is beneficial to patients with CHF in the long term and whether it improves life expectancy and keeps them out of hospital. This study will help us answer these key questions.
This study will address whether the additional use of Intravenous (IV) iron on top of standard care will improve the outlook for patients with heart failure and iron deficiency. One group of participants will receive treatment with iron injections and the other group will not receive any iron injections.
The study will take place in about 70 secondary care sites (hospitals) across the UK. Participants will be recruited over a period of about five years and will be followed up for a minimum of three months (average duration of about four years per participant). After the initial visits, participants will be seen every four months.
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
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Standard care plus IV iron infusion
Iron to be administered as iron (III) isomaltoside 1000 / ferric derisomaltose.
Infused over a minimum of 15 mins for doses up to and including 1000mg, and a minimum of 30 mins for doses >1000mg
Where Hb ≥10 g/dL, dosage according to body weight is as follows:
Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 1000 mg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 1500 mg.
Where Hb <10 g/dL, dosage according to body weight is as follows:
Body weight <50 kg: 20 mg/kg; Body weight 50 to <70 kg: 20 mg/kg; Body weight ≥70 kg: 20 mg/kg up to a maximum of 2000 mg.
干预措施: Ferric Derisomaltose (Drug)
结局指标
主要结局
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
时间窗: Minimum of 3 months follow-up from last patient recruited
次要结局
- Cardiovascular mortality(Minimum of 3 months follow-up from last patient recruited)
- All-cause hospitalisation (first event)(Minimum of 3 months follow-up from last patient recruited)
- Physical domain of QoL (Minnesota Living With Heart Failure)(At 20 months)
- Hospitalisation for worsening heart failure (recurrent events)(Minimum of 3 months follow-up from last patient recruited)
- Overall Score from Minnesota Living with Heart Failure(At 4 months)
- Overall EQ-5D index(At 20 months)
- Combined all-cause mortality or first all-cause unplanned hospitalisation(Minimum of 3 months follow-up from last patient recruited)
- CV hospitalisation (first event)(Minimum of 3 months follow-up from last patient recruited)
- CV death or hospitalisation for heart failure analysed as time to first event(Minimum of 3 months follow-up from last patient recruited)
- Overall EQ-5D VAS(At 20 months)
- CV mortality or hospitalisation for major CV event (stroke, MI, heart failure) (first event)(Minimum of 3 months follow-up from last patient recruited)
- All-cause mortality(Minimum of 3 months follow-up from last patient recruited)
- Overall Score from Minnesota Living With Heart Failure(At 20 months)
- Quality-adjusted days alive and out of hospital(At 12 months)
- Death due to infection(Minimum of 3 months follow-up from last patient recruited)
- Hospitalisation primarily for infection (first event)(Minimum of 3 months follow-up from last patient recruited)
- Days dead or hospitalised(At 36 months)
- 6 minute walk test(At 20 months)
研究者
Paul Kalra
Chief Investigator
University of Glasgow