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: Drug: Ferric Derisomaltose

• 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.

Study Timeline

• Study First Submitted: 2015-12-24
• Study First Submitted QC: 2015-12-29
• Study First Posted: 2015-12-30
• Study Start: 2016-08
• Primary Completion: 2022-08-26
• Study Completion: 2022-08-26
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-28

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

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

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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