Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN
- Conditions
- Left Ventricular Systolic DysfunctionChronic Heart FailureIron Deficiency
- Interventions
- Registration Number
- NCT02642562
- Lead Sponsor
- University of Glasgow
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care plus IV iron infusion Ferric Derisomaltose 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.
- Primary Outcome Measures
Name Time Method CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations) Minimum of 3 months follow-up from last patient recruited
- Secondary Outcome Measures
Name Time Method 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 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 Cardiovascular mortality Minimum of 3 months follow-up from last patient recruited CV hospitalisation (first event) Minimum of 3 months follow-up from last patient recruited
Related Research Topics
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Trial Locations
- Locations (72)
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
University Hospital Monklands
🇬🇧Airdrie, United Kingdom
Antrim Area Hospital
🇬🇧Antrim, United Kingdom
Wansbeck General Hospital
🇬🇧Ashington, United Kingdom
Barnet Hospital
🇬🇧Barnet, United Kingdom
Basildon University Hospital
🇬🇧Basildon, United Kingdom
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Scroll for more (62 remaining)Aberdeen Royal Infirmary🇬🇧Aberdeen, United Kingdom