A total of 1300 patients who suffer from chronic heart failure or iron deficiency will take part in the UK-wide IRONMAN trial, which will be led by the University of Glasgow and Greater Glasgow and Clyde Health Board.
People with heart failure often have low levels of usable iron in the blood, and this is associated with worse symptoms. Previous smaller studies have shown that intravenous iron can be beneficial to patients with heart failure in the short term, making them feel better and increasing exercise capacity.
Key end points
Study leader Dr Paul Kalra, who is consultant cardiologist from Portsmouth Hospitals NHS Trust and honorary senior lecturer at the University of Glasgow, said the study would “build on this evidence” by looking at “key end points” over a longer period and in a larger patient group.
“Before creating clinical guidelines, we need to see whether iron supplementation is safe, keeps people alive, reduces hospitalisation and continues to help people feel better in the long term,” he told NutraIngredients.
Asked whether iron supplement injections were currently being administered as a treatment for heart failure patients anywhere in Europe, Dr Kalra said that there were “small pockets” of people using iron immunisation, but that it wasn’t being done systematically anywhere because of a lack of data.
Randomised, multi-centre study
The 1,300 patients across 50 UK sites will be randomised to receive the best possible care for heart failure or the best possible care plus iron supplementation. They will be followed up for a minimum of two years (and up to four years) to determine whether intravenous iron can reduce the incidence of cardiovascular death and hospitalisation.
During the trial period patients will be seen every four months, and those in the iron supplementation group will be given iron only if they need it.
“We estimate that the frequency will be once a year,” said Dr Kalra.
The iron supplement to be used in the trial is Monofer (iron isomaltoside 1,000), a high dose iron drug for intravenous application produced by Danish firm PharmaCosmos.
“We chose Monofer as it enables a high dose over a short period of time, so sits well with the majority of outpatients,” explained Dr Kalra.
He said the dose would be up to a maximum of 2 g, dependent on the weight and haemoglobin levels of individual patients.
Dr Kalra said the first patients would be recruited within the next two to three weeks, with a view to recruiting all 1,300 participants in the next two years. He estimated that from start to completion, the study would take just over four years.