Effectiveness of intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)
NHS Greater Glasgow & Clyde
Duration of Study in the UK
5 years, 0 months, 1 days
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 out look 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 50 secondary care sites (hospitals) across the UK.
Participants will be recruited over a period of two years and will be followed up for a minimum of two and a half years (average duration of three years per participant). After the initial visits, participants will be seen every four months.
East Midlands - Leicester South Research Ethics Committee
Date of REC Opinion
24 Dec 2015