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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,160
CV mortality or hospitalisation for worsening heart failure (analysis will include first and recurrent hospitalisations)
Time frame: Minimum of 3 months follow-up from last patient recruited
Hospitalisation for worsening heart failure (recurrent events)
Time frame: Minimum of 3 months follow-up from last patient recruited
CV hospitalisation (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
CV death or hospitalisation for heart failure analysed as time to first event
Time frame: Minimum of 3 months follow-up from last patient recruited
Overall Score from Minnesota Living with Heart Failure
Time frame: At 4 months
Cardiovascular mortality
Time frame: Minimum of 3 months follow-up from last patient recruited
Overall EQ-5D VAS
Time frame: At 4 months
Overall EQ-5D index
Time frame: At 4 months
CV mortality or hospitalisation for major CV event (stroke, MI, heart failure) (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
All-cause mortality
Time frame: Minimum of 3 months follow-up from last patient recruited
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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
...and 62 more locations
All-cause hospitalisation (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited
Combined all-cause mortality or first all-cause unplanned hospitalisation
Time frame: Minimum of 3 months follow-up from last patient recruited
Physical domain of QoL (Minnesota Living With Heart Failure)
Time frame: At 4 months
Physical domain of QoL (Minnesota Living With Heart Failure)
Time frame: At 20 months
Overall EQ-5D VAS
Time frame: At 20 months
Overall EQ-5D index
Time frame: At 20 months
Overall Score from Minnesota Living With Heart Failure
Time frame: At 20 months
Days dead or hospitalised
Time frame: At 36 months
Quality-adjusted days alive and out of hospital
Time frame: At 12 months
6 minute walk test
Time frame: At 4 months
6 minute walk test
Time frame: At 20 months
Death due to infection
Time frame: Minimum of 3 months follow-up from last patient recruited
Hospitalisation primarily for infection (first event)
Time frame: Minimum of 3 months follow-up from last patient recruited