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Intravenous Iron Treatment in Patients With Heart Failure and Iron Deficiency: IRONMAN

Phase 4
Completed
Conditions
Left Ventricular Systolic Dysfunction
Chronic Heart Failure
Iron 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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard care plus IV iron infusionFerric DerisomaltoseIron 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
NameTimeMethod
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
NameTimeMethod
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 FailureAt 4 months
Overall EQ-5D indexAt 20 months
Combined all-cause mortality or first all-cause unplanned hospitalisationMinimum of 3 months follow-up from last patient recruited
CV death or hospitalisation for heart failure analysed as time to first eventMinimum of 3 months follow-up from last patient recruited
Overall EQ-5D VASAt 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 mortalityMinimum of 3 months follow-up from last patient recruited
Overall Score from Minnesota Living With Heart FailureAt 20 months
Quality-adjusted days alive and out of hospitalAt 12 months
Death due to infectionMinimum 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 hospitalisedAt 36 months
6 minute walk testAt 20 months
Cardiovascular mortalityMinimum of 3 months follow-up from last patient recruited
CV hospitalisation (first event)Minimum of 3 months follow-up from last patient recruited

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

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Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom

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