IRONMAN – Effectiveness of intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial.

IRONMAN is a ground-breaking clinical trial that is investigating whether intravenous iron can improve life expectancy in patients with heart failure and keep them out of hospital. We are also hoping to find out if this treatment helps patients feel better and allows them to carry out daily activities more effectively.

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.

WHAT IS HEART FAILURE?
Heart failure is a condition in which the heart doesn’t pump effectively. This can leave people unable to carry out everyday tasks such as climbing the stairs or walking to the shops.

WHAT IS THIS STUDY ABOUT?
Patients with heart failure commonly have iron deficiency (low iron levels) and this is thought to contribute to the symptoms they experience, including shortness of breath and fatigue. Research has suggested that by treating iron deficiency with iron injections (intravenously), patients may feel better. We need more information to find out if treating iron deficiency in patients with heart failure can reduce the need to be admitted to hospital, or improve life expectancy and improve their sense of wellbeing.

WHO CAN JOIN IRONMAN?
People who are over the age of 18 with heart failure and iron deficiency may be eligible to take part in the IRONMAN study. You must be able to provide your consent to take part in the study.

WHY MIGHT I BE CHOSEN?
Approximately half of patients with heart failure have iron deficiency. If you have heart failure and iron deficiency you may be suitable to take part in this study and could help us understand whether treatment with iron injections are helpful.

WHAT DOES TAKING PART INVOLVE?
The IRONMAN study will gather information about whether treatment with intravenous iron is effective in reducing the adverse consequences of heart failure. Participants will help us to determine whether intravenous iron is safe, improves quality of life and is a good treatment to be used within the NHS.

  • We will ask you if you are happy for us to follow your health progress through your medical records
  • You will be allocated to either receive intravenous iron or not.
  • You will be asked to attend study visits at which we will collect data on risk factors for heart disease and medical events you have previously experienced and experience during the study. We will also carry out blood tests and clinical assessments to monitor your health.

WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF PARTICIPATING?
If you are allocated to iron treatment, you may experience side effects related to the iron therapy but these are rare. Your initial screening test may reveal that you have a medical problem of which both you and we were unaware and we may not be able to enter you into the study. Naturally, we will ensure that you receive an explanation, investigation and treatment of any new problem in the usual way. Blood sampling may cause minor discomfort and bruising.

WHAT ARE THE POSSIBLE BENEFITS OF TAKING PART?
If you receive the iron treatment and it is successful, and your iron deficiency improves or resolves completely, we are hoping that you will feel better and experience less breathlessness and fatigue and have fewer hospital admissions. Whether you receive iron or not, we will monitor your health closely throughout the study. However, there is no guarantee you will benefit in any way. Nevertheless, results from this study may provide information which will help us to treat heart failure patients with iron deficiency more successfully in the future.

HOW MANY PATIENTS WILL BE INVOLVED?
1300 patients across England, Scotland, Wales and Northern Ireland will be involved in the study.

WHAT IS THE DRUG BEING TESTED?
The iron preparation being used is called Monofer®. It has been approved in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA) at a similar dose for treatment of patients who have been diagnosed with iron deficiency. It is given as an infusion into the vein over 15-30 minutes, depending on the dose given.

RESEARCH OBJECTIVES
The principal research objective is to establish in patients with chronic heart failure and iron deficiency whether treatment with intravenous iron is effective in reducing death due to cardiovascular problems, and hospitalisation due to heart failure. The secondary research objectives are to determine whether intravenous iron is safe, improves quality of life and is cost effective.

YOUR DATA

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.

Record Linkage Process
Record linkage is the way that we receive data from centralised electronic databases regarding any hospital admissions, new diseases, prescribing records and deaths. It is important for us to receive this information as it helps us to identify important medical events affecting patients within the study such as admissions to hospital due to heart failure or heart attacks or strokes. Participants can withdraw consent for accessing medical records (including record-linkage) at any time by letting their IRONMAN nurse know.

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.

The following information applies to IRONMAN study participants in England and Wales:
The Health and Social Care Information Centre (HSCIC, known as NHS Digital) was established in April 2013 and is responsible for providing a trusted Safe Haven for some of an individual's most sensitive health and social care information.

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.

For further information about NHS Digital or HES data, please click on the links below:
Link to NHS Digital
Link for HES data

The following information applies to IRONMAN study participants in Scotland:
In Scotland, specific departments within the health service collect information from the records that care providers keep about individuals using their services. The data are collected from a wide range of providers across Scotland, ranging from hospitals to general practices. In Scotland from the organisation holding the data is called ISD Scotland.

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.

Data Management for the study – Robertson Centre for Biostatistics, University of Glasgow
The IRONMAN study is led by the University of Glasgow (the data controller) and Queen Alexandra Hospital in Portsmouth (the Chief Investigator’s site). The Robertson Centre for Biostatistics, University of Glasgow, acts as the data processing centre and as such are responsible for the storage, data management and processing of the data relating to the IRONMAN study. The Robertson Centre is an ISO27001 (security certificate) approved academic unit within the University of Glasgow that has extensive experience in handling patient data for clinical trials and undergoes regular audits and inspections. The data relating to the IRONMAN study will be stored and analysed at the University of Glasgow in accordance with approved study procedures. This collaboration is described in the study protocol and has been included in all relevant approvals, such as approval by a national ethics committee. The Robertson Centre is regarded as part of the IRONMAN study team.

If you would like to discuss any of what is described above, please contact the study team using the contact details on this website.

General Data Protection Regulation (GDPR) information
NHS Greater Glasgow & Clyde and the University of Glasgow are the sponsors for this study based in the United Kingdom.

How will we use information about you?

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.

What are your choices about how your information is used?

  • You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have.
  • If you choose to stop taking part in the study, we would like to continue collecting information about your health from central NHS records/your hospital/your GP. If you do not want this to happen, tell us and we will stop.
  • We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you.
  • If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study. If you have consented to having samples taken for use in this and future ethically approved studies these will be labelled with a code and stored within a biobank at the University of Leicester.

Where can you find out more about how your information is used?

You can find out more about how we use your information

Isobel Brown
Data Protection Officer
NHS Greater Glasgow and Clyde
1 Smithhills Street
Paisley
PA1 1EB

CONTACT
If you have any questions about the IRONMAN Study please contact the Trial Manager, Lizzie Thomson – Elizabeth.Thomson@glasgow.ac.uk