The IRONMAN trial, which was funded by the British Heart Foundation, looked at more than one thousand symptomatic patients with a type of heart failure where their ejection fraction (strength of heart muscle contraction) was reduced. Many patients were recruited from the community, rather than during acute hospital admissions, making them representative of people living with heart failure in the community. Patients, all of whom had low iron levels, were split into two groups, with one group receiving normal care, and the second group receiving normal care plus doses of intravenous (IV) iron (a drip into a vein). The progress of patients was followed for more than two and a half years on average.
As many patients will know, the COVID-19 pandemic upset a lot of the care given to patients. It was no different for people on the trial and for periods of time it was not possible for the research doctors and nurses to see patients in-person to check progress directly, to review iron levels and to re-dose with IV iron as necessary. As such analyses of the results to try and remove the impact of COVID-19 on the results were also performed.
The headline outcomes of the trial were that with IV iron:
The results have been reviewed by international experts writing guidelines for clinicians and alongside other trial data around IV iron use in heart failure. These guidelines have been updated and IV iron is recommended for those patients who are iron deficient to help symptoms and reduce the risk of being admitted to hospital due to heart failure.
In taking part in the IRONMAN study, participants consented to the research team following up their health status for up to 10 years after the end of the study using data supplied by the Information Services Division (ISD) of NHS Scotland and NHS Digital in England/Wales. We would like to update you on how we are currently using your data, what is involved in the process of record-linkage and to explain the involvement of NHS England (formerly known as NHS Digital).
NHS England collects information from the records that health and social care providers keep about individuals using their services. The data is collected from a wide range of providers across England and Wales, ranging from hospitals to general practices.
One of the datasets collected is called Hospital Episode Statistics (HES). This is information about patients in relation to their NHS visits and stays at hospitals in England and Wales. The information collected contains details of admissions to hospital, outpatient appointments, and A&E attendances. We also will get death certification data.
We need to tell NHS England who you are, so that they can supply your records to us. We will supply your IRONMAN study participant number, NHS Number, date of birth, postcode, and name, and NHS England will return your hospital, cancer registration and mortality records to us identified by your unique IRONMAN study participant number only. All transfer of data is handled securely and confidentially, in line with NHS standards.
For further information about NHS England or HES data, please click on the links below:
Link to NHS England
Link for HES data
One of the datasets collected is related to hospital admissions. This is information about patients in relation to their NHS visits and stays in hospitals. The information collected contains details of admissions to hospital, outpatient appointments, and A&E attendances. We will also get death certification data.
In order that they can supply your records to us we will supply them with your IRONMAN study participant number and Community Health Index number, and Public Health Scotland will return your hospital and mortality records to us identified by your unique IRONMAN study participant number only. All transfer of data is handled securely and confidentially, in line with NHS standards.
For further information about Public Health Scotland please click on the link below:
If you would like to discuss any of what is described above, please contact the study team using the contact details on this website.
We will need to use information from you, from your medical records, from your GP and from national databases for this research project.
This information will include your initials/NHS or CHI number/name/contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead.
We will keep all information about you safe and secure.
In future, some of your information may be sent to other countries. They must follow our rules about keeping your information safe. No personal data will be shared.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
You can find out more about how we use your information
Data Protection Officer
NHS Greater Glasgow and Clyde
1 Smithhills Street
Paisley
PA1 1EB