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 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
Trial Locations
- Locations (72)
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
St. George's Hospital
🇬🇧Tooting, United Kingdom
Torbay Hospital
🇬🇧Torquay, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom
Watford General Hospital
🇬🇧Watford, United Kingdom
Wansbeck General Hospital
🇬🇧Ashington, United Kingdom
Barnet Hospital
🇬🇧Barnet, United Kingdom
University Hospital Monklands
🇬🇧Airdrie, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Antrim Area Hospital
🇬🇧Antrim, United Kingdom
Basildon University Hospital
🇬🇧Basildon, United Kingdom
Basingstoke and North Hampshire Hospital
🇬🇧Basingstoke, United Kingdom
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Blackpool Victoria Hospital
🇬🇧Blackpool, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Princess of Wales Hospital
🇬🇧Bridgend, United Kingdom
Royal Sussex County Hospital
🇬🇧Brighton, United Kingdom
Bristol Royal Infirmary
🇬🇧Bristol, United Kingdom
Broomfield Hospital
🇬🇧Chelmsford, United Kingdom
St. Richard's Hospital
🇬🇧Chichester, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Croydon University Hospital
🇬🇧Croydon, United Kingdom
Darlington Memorial Hospital
🇬🇧Darlington, United Kingdom
Doncaster Royal Infirmary
🇬🇧Doncaster, United Kingdom
Ulster Hospital
🇬🇧Dundonald, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Wycombe General Hospital
🇬🇧High Wycombe, United Kingdom
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
University Hospital Crosshouse
🇬🇧Kilmarnock, United Kingdom
West Middlesex University Hospital
🇬🇧Isleworth, United Kingdom
Kingston Hospital
🇬🇧Kingston upon Thames, United Kingdom
Forth Valley Royal Hospital
🇬🇧Larbert, United Kingdom
Victoria Hospital
🇬🇧Kirkcaldy, United Kingdom
Glenfield Hospital
🇬🇧Leicester, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, United Kingdom
Liverpool Heart and Chest Hospital
🇬🇧Liverpool, United Kingdom
University Hospital Llandough
🇬🇧Llandough, United Kingdom
Royal Glamorgan Hospital
🇬🇧Llantrisant, United Kingdom
Guy's and St. Thomas' Hospital
🇬🇧London, United Kingdom
Hammersmith Hospital (Imperial College)
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
North Middlesex University Hospital
🇬🇧London, United Kingdom
St. Bartholomew's Hospital
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
Wythenshawe Hospital
🇬🇧Manchester, United Kingdom
Royal Gwent Hospital
🇬🇧Newport, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Poole Hospital
🇬🇧Poole, United Kingdom
Royal Alexandra Hospital
🇬🇧Paisley, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Salford Royal Hospital
🇬🇧Salford, United Kingdom
Salisbury District Hospital
🇬🇧Salisbury, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
University Hospital Southampton
🇬🇧Southampton, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, United Kingdom
City Hospitals Sunderland
🇬🇧Sunderland, United Kingdom
Great Western Hospital
🇬🇧Swindon, United Kingdom
Harefield Hospital
🇬🇧Harefield, United Kingdom
Southend University Hospital
🇬🇧Southend, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom
Castle Hill Hospital
🇬🇧Hull, United Kingdom