The trial will involve 1300 patients from over 65 sites, which will make this the biggest iron study worldwide in heart failure to date. The IRONMAN study is being led by Prof. Paul Kalra, Consultant Cardiologist at Queen Alexandra Hospital, Portsmouth and Chair of the British Society for Heart Failure.
Patients will be recruited over a period of five years and followed up for at least six months (average duration of four years per participant). After the initial visits, participants will be seen every four months.
Over the course of the study you will meet with a study nurse and information on your medical condition, medical history and the progress of your treatment will be recorded and stored in our study database. Some of this information may be taken from your medical notes. The information recorded will include confirmation of your consent to take part, your past medical history, what medicines you take and your contact details.
We will hold all of this information in a secure electronic database which is located within the Robertson Centre for Biostatistics, University of Glasgow. The study data can only be accessed by authorised members of the study team and the data management staff in the Robertson Centre of Biostatistics. All personnel accessing the information have Good Clinical Practice training and are contractually bound to uphold confidentiality.
The information stored in the database will include an electronic copy of your signed consent form.
The University of Glasgow will keep your name, your unique NHS identifier (Community Health Index or NHS number) and contact details confidential and will not pass this information to any unauthorized personnel. Approved personnel within the Study will use this information as needed, to contact you about the research study, and make sure that relevant information about the study is recorded for your care, and to oversee the quality of the study. Certain individuals from the University of Glasgow as the sponsor organisation and regulatory organisations may look at your medical and research records to check the accuracy of the research study.
The people who analyse the information will not be able to identify you and will not be able to find out your name, your unique NHS identifier or contact details. The University of Glasgow will keep identifiable information about you from this study for 25 years after the study has finished.
The Study will collect information about you for the IRONMAN study from the NHS, this process is called record linkage and is described below.
In taking part in the IRONMAN study, participants consent to the research team following up their health status 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 Digital.
NHS Digital 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 Digital who you are, so that they can supply your records to us. We will supply a list of individual’s details (NHS Number, date of birth, postcode, gender), and NHS Digital will return your hospital and mortality records to us identified by your unique IRONMAN study participant number. All transfer of data is handled securely and confidentially, in line with NHS standards.
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.
In order that they can supply your records to us we will supply a list of individual’s details (Community Health Index number, date of birth, postcode, gender), and ISD Scotland will return your hospital and mortality records to us identified by your unique IRONMAN study participant number. All transfer of data is handled securely and confidentially, in line with NHS standards.
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