Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)'
University of Glasgow · Academic
In term In term in the September 2026 edition: the latest version runs to 30 January 2028.
- Reference
- DARS-NIC-433923-Z0V8D
- Current version
- v2.2
- Term of current version
- 31 January 2025 to 30 January 2028
- Start date
- 1 February 2022
- Data controller
- Sole Data Controller
- Commercial purposes
- Yes
- Sublicensing
- No
- Files released to date
- 6
Why the data was released
Objective for processing
IRONMAN (Effectiveness of IntRavenous irON treatMent vs standard care in pAtieNts with heart failure and iron deficiency) is a randomised trial of Intravenous (IV) iron involving 1400 study participants with heart failure and iron deficiency in England and Wales, powered to detect effects on morbidity, mortality and cost-effectiveness that will inform clinical management and international guidelines. The Trial is being run by researchers in the Robertson Centre for Biostatistics (RCB) at the University of Glasgow
The trial will look at whether there is evidence that the addition of IV iron to standard care is of benefit. It is an investigator-designed and initiated study. It will utilise a PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) design. That is, the participants will be randomised to normal care or intravenous iron therapy with the participants and their physicians being aware of the treatment received. The study outcomes will be reviewed and adjudicated by an expert group who have no access to the randomisation arm the participants have been allocated to. Participants will be assigned to receive IV iron or not, in addition to guideline-indicated care. Participants assigned to IV iron will receive repeated doses sufficient to ensure iron repletion for the duration of the study. For participants consenting to collection of blood samples, samples will be stored for a biobank sub-study involving future analysis of biomarkers related to the progression of heart failure and patient outcomes. It is an event-driven trial, but it is expected that participants will be treated for between six months and 5.5 years. The study commenced in 2016 and is ongoing. Recruitment completed in October 2021 and the study follow up is expected to complete in March 2022. Long-term follow up will be for up to 10 years after recruitment ended.
Hospital Episode Statistics (HES) data will not include data for those treated at Welsh hospitals.
There was Public and Patient Involvement (PPI) in the trial design; the West Middlesex patient cardiomyopathy support group provided input and the draft protocol was reviewed by an independent heart failure service (Gloucestershire – heart failure nurse specialists and patients, coordinated by Head of Specialist Services). Full endorsement was given to the need for the study. There is also a patient representative on the Trial Steering Committee (TSC).
The pseudonymised record-level data requested from NHS England will allow the study researchers to obtain events (hospitalisations, cancers and deaths) in the year prior to the study participant's consent date, during study participation and up to ten years after the study end. As this is a morbidity/mortality study, follow up for clinical events is critical.
The University of Glasgow relies on the following Articles for General Data Protection Regulations (GDPR) lawful basis for data processing. Article 6(1)(e) (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller)– The University of Glasgow are under a Royal Charter and NHS England are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described herein and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.
Additionally, as health data is a special category of personal data, Article 9(2)(j) (archiving in the public interest, scientific or historical research or statistical purposes). The data is required for research purposes meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The Data Protection Act 2018 Schedule 1 Part 1 states that when processing special category data under the condition relating to research, the condition is met when:
(a) 'necessary for archiving purposes, scientific or historical research purposes or statistical purposes'. As described above the data is considered necessary for the performance of the task
(b) 'carried out in accordance with Article 89(1) of the GDPR'. In accordance with this article, processing is subject to appropriate safeguards. These include:
i. The data will be pseudonymised prior to dissemination by NHS England to the data recipient;
ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS England’s acceptance criteria (see sections 2 and 5b of this application for further details);
iii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection (see sections 5a, 5b and 8a of this application for further details);
(c) 'is in the public interest'. NHS England is content that the information set out in the Benefits section of the application evidences that the data processing will be in the public interest - This study could result in a change to treatment guidelines in the way patients with heart failure are treated – therefore demonstrating that the processing is in the public interest. Data linkage will provide a more complete and objective record of study events than is otherwise available from local records.
The requested data are record level pseudonymised Cancer Registration data, Civil Registration (Deaths) data, and Hospital Episode Statistics (HES) – Admitted Patient Care (APC).
In terms of data minimisation, the study team are only requesting NHS England data necessary to detect study serious adverse events, potential endpoints and primary and secondary outcomes linked to 1,400 IRONMAN consented patients from one year prior to date of consent and up to ten years after study end. Clinical trials are required to collect data on Serious Adverse Events that include hospital admissions, deaths, and cancers.
The project has minimised the data requested for the consented population to those data elements needed to address the research questions and only access to pseudonymised data for up to one year prior to consent is requested. The study team have limited the fields to only those requested to fulfil the study analysis. Pseudonymised record-level patient data will be held on the Robertson Centre for Biostatistics (RCB) Analytical Platform. More information on this platform can be found in section 5(b) below. The study researchers, who are substantive employees of the University of Glasgow, will link the NHS England record-level pseudonymised data to the data collected in the IRONMAN study using a numerical study pseudo-identifier only to study concordance of the different sources of information. There are no other ways to obtain these data.
The only record-level identifiable data linkage permitted under this agreement is the linkage of the cohort identifiers provided to NHS England by University of Glasgow (IRONMAN ID number, NHS number, date of birth, postcode and name) to the NHS England data sets requested in this agreement expressly for means of extraction. Pseudonymised record-level data will only be accessed by substantive employees of the University of Glasgow, and will not be shared with any organisation, including funding organisations.
University of Glasgow is the Data Controller who also processes data for the purposes of this agreement.
This study is funded by the British Heart Foundation with support from Pharmacosmos in terms of the investigational medicinal product (IMP)who also provide additional financial support. Neither the British Heart Foundation nor Pharmacosmos have a designated role or responsibility in trial design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results. Neither the British Heart Foundation nor Pharmacosmos will have access to record-level data from NHS England. As a result, neither organisation are considered a Data Controller or Data Processor. A representative from Pharmacosmos will be invited to attend Trial Steering Committee (TSC) meetings as an observer and non-voting member. All members of the TSC are allowed to speak at meetings and as Pharmacosmos provide the drug for this study and distribute to the study sites, their input into study drug supply and distribution is invaluable. Pharmacosmos have no influence in the design or conduct of the study. Support from Pharmacosmos will be acknowledged in any publications related to the study.
The purpose of this study is to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective and, therefore, purpose is research into public health and aiming to benefit to health and social care in England. However, in the interests of transparency, it is noted here that the results of this study may contribute towards commercial work resulting in financial benefit for Pharmacosmos which, in turn, may provide further funding for research into the population. If the study demonstrates clear evidence of benefit of IV Iron treatment for heart failure patients then Pharmacosmos may in future submit data from the trial to the regulatory authorities in the UK, European Union and elsewhere. In this scenario, the recipient(s) would have no access to the participant identifier code/key and no data provided by NHS England would be shared with Pharmacosmos nor any other third party. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
IRONMAN trial ended in August 2022, however the long-term follow-up via record linkage is continuing as described in the trial protocol.
Processing activities
Data will be held and processed only by the study researchers, who are substantive employees of the University of Glasgow, who have been appropriately trained in data protection and confidentiality. Processing of data linkage data will be carried out on University-owned devices within the Robertson Centre for Biostatistics (RCB) secured office space or via remote access to these devices via Virtual Private Network (VPN). VPN access for RCB staff will be via authorised University-owned laptops or computers. Any data outputs shared outside of the University of Glasgow will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.
Summary reports of serious adverse events are made to the Medicines and Healthcare products Regulatory Agency (MHRA) in line with clinical trials requirements. Any suspected unexpected serious adverse reaction reports will be at a patient level. These reports will be based on information obtained from the hospitals participating in the trial and entered into the study electronic Case Report Form. No records obtained from NHS England will be shared with regulatory agencies.
The Robertson Centre for Biostatistics (part of the University of Glasgow) will provide:
- Data management (including electronic Case Report Form design, database setup and management, data validation)
- Statistical analysis and reporting (final report, Independent Data Monitoring Committee reports)
- Data management and statistical support to record linkage
- Provision of support for issues relating to data quality and use of endpoint adjudication system
- Project Management and Quality Assurance
- Transfer of patient identifiers to NHS England and receipt of record-level pseudonymised data from NHS England
Record-linkage for events will be carried out. For any events that appear not to have been previously reported, study sites will be asked to investigate and to report details of previously unreported events in the electronic Case Report Form. To do this, the study team will share record-level data with the study sites purely for the purpose of data completion. For hospitalisations, the study team will provide the study site with date of hospitalisation and the hospital which the participant was admitted to. For deaths, the study team will provide the study sites with date of death and location of death (hospital to be specified or out of hospital). Based on information obtained from the sites, clinical events that constitute important endpoints in the trial will be adjudicated by an endpoint committee without knowledge of the treatment group to which patients were allocated.
Data analysis will be carried out according to a pre-specified plan which will be completed and signed off before the study database is finalised.
METHODOLOGY
1. The Robertson Centre will provide NHS England with the following identifiable data for the 1,400 consented study participants: NHS Number, name, postcode, date of birth, consent date (which will be either date of consent OR date of consent minus 12 months, if the participant has consented to this) individual study ID and end date (which will be either date of extract or date of withdrawal, where applicable) via NHS England’s Secure Electronic File Transfer Service (SEFT).
2. NHS England will link and extract the requested data and return the pseudonymised data files with the study ID only to the University of Glasgow via SEFT.
3. The data will be downloaded from SEFT to, and processed via, the Robertson Centre Safe Haven at the University of Glasgow, within a secure network. Summary reports will be prepared and any additional information from the study database will be included (i.e. adjacent events already reported via the study web portal) with linkage occurring only using the pseudonymised study ID. Clinically qualified study staff will review the reports, via the Robertson Centre analytical environment (this is a secure, partitioned area within the Safe Haven), and mark up to indicate any events that should be followed up.
Analyses based on data linkages carried out after the end of trial follow up will be performed in a separate secure database containing record linkage data and data from the trial database. These analyses will take place within the Robertson Centre’s secured work environment. All outputs from these analyses will be subject to disclosure control. No record-level NHS England data will be forwarded to regulatory authorities. Identifiable record-level data is kept in a separate secure section of the Robertson Centre’s secured work environment to the pseudonymised NHS England record-level data.
All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract i.e.: employees, agents and contractors of the Data Recipient who may have access to that data).
HES and ECDS DISCLOSURE CONTROL / SMALL NUMBER SUPPRESSION
In order to protect patient confidentiality, when presenting results calculated from HES record level data, outputs will contain only aggregate level data with small numbers suppressed in line with HES Analysis Guide. When publishing HES data, data processors must make sure that:
• National-level figures only may be presented unrounded, without small number suppression
• cell values from 1 to 7 (inclusive) are suppressed at a sub-national level to prevent possible identification of individuals from small counts within the table.
• Zeros (0) do not need to be suppressed.
• All other counts will be rounded to the nearest 5.
Data will not be made available to any third parties other than those specified except in the form of aggregated outputs with small numbers suppressed in line with the HES Analysis Guide.
Expected output
All Outputs including data will be aggregated with small number suppressed as per the HES analysis guide.
Results are expected to be reported in a peer-reviewed journal and at major scientific and clinical meetings. This is expected in 2022.
The research team believe that the results of this study would be of interest to a high impact factor journal. The research team intend to organise press releases to coincide with the publication to promote knowledge mobilisation of the study results. The findings are expected to be presented at major cardiovascular scientific and clinical meetings (e.g. European Society of Cardiology or American Heart Association meetings.)
The research team intend to produce a non-technical summary of the results which will be sent to patients who participated in the trial, patient groups and cardiovascular charities. The University of Glasgow aims to release a press release in collaboration with the British Heart Foundation. The research team will also work to generate media coverage of the study results (in aggregated with small numbers suppressed format) and communicate these to the wider public. Target date 2022.
Outputs may also be shared with funders, but ownership and control of the outputs rests with the University of Glasgow.
All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
Expected measurable benefits
The IRONMAN study team aim to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective.
Patients with heart failure often have reduced quality of life due to symptoms. The diagnoses also causes a significant psychological impact on patients due to concerns about mortality and impairment of lifestyle. An intervention, such as that is the IRONMAN study, that could be given as standard care on the NHS and could improve symptoms, functional capacity and quality of life would be of great benefit to patients.
All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. Likewise, if the study raises any significant safety concerns this could also lead to changes in treatment guidelines.
The study team believes that it is very important that they capture all deaths, hospitalisations and cancers, and the NHS England record-level pseudonymised data will help them to achieve this objective.
Benefits reported so far
The initial linkage has identified a number of previously unreported clinical events. Hence, the linkage is very important for accurate reporting of the results of the clinical trial. The additional linkage will provide more complete coverage of the period of follow-up in the trial as is likely to identify additional unreported events. It will provide validation of record linkage for identifying cardiovascular deaths and heart failure hospital admissions. This could simplify and reduce the cost of future clinical trials in heart failure.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 – s261(2)(c)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Cancer Registration Data | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Consent (Reasonable Expectation) |
| Civil Registrations of Death | Anonymised - ICO Code Compliant | Sensitive | One-Off | Consent (Reasonable Expectation) |
| Hospital Episode Statistics Admitted Patient Care (HES APC) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Consent (Reasonable Expectation) |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
Patient opt-outs were not applied to any of the 6 files released under this agreement, across every version. About opt-outs
No files recorded as released under the current version. 6 were released under earlier versions, shown in the version history.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-433923-Z0V8D-v2.2 31 January 2025 to 30 January 2028
- Title
- Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)'
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 3
- Files released
- 0
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC)
What changed from DARS-NIC-433923-Z0V8D-v1.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-01-31 | |
| End date | 2028-01-30 |
Objective for processing
[4 paragraphs unchanged]
The pseudonymised record-level data requested from NHS
Digital
England
will allow the study researchers to obtain events (hospitalisations, cancers and deaths)
[23 words unchanged]
this is a morbidity/mortality study, follow up for clinical events is critical.
The University of Glasgow relies on the following Articles for General Data
[33 words unchanged]
controller)– The University of Glasgow are under a Royal Charter and NHS
Digital
England
are satisfied that this request is appropriate, necessary and proportionate for the
[18 words unchanged]
to achieve their purpose that is less intrusive to the data subjects.
[3 paragraphs unchanged]
i. The data will be pseudonymised prior to dissemination by NHS
Digital
England
to the data recipient;
ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS
Digital’s
England’s
acceptance criteria (see sections 2 and 5b of this application for further details);
[2 paragraphs unchanged]
(c) 'is in the public interest'. NHS
Digital
England
is content that the information set out in the Benefits section of
[52 words unchanged]
objective record of study events than is otherwise available from local records.
[1 paragraph unchanged]
In terms of data minimisation, the study team are only requesting NHS
Digital
England
data necessary to detect study serious adverse events, potential endpoints and primary
[31 words unchanged]
data on Serious Adverse Events that include hospital admissions, deaths, and cancers.
The project has minimised the data requested for the consented population to
[73 words unchanged]
are substantive employees of the University of Glasgow, will link the NHS
Digital
England
record-level pseudonymised data to the data collected in the IRONMAN study using
[11 words unchanged]
sources of information. There are no other ways to obtain these data.
The only record-level identifiable data linkage permitted under this agreement is the linkage of the cohort identifiers provided to NHS
Digital
England
by University of Glasgow (IRONMAN ID number, NHS number, date of birth, postcode and name) to the NHS
Digital
England
data sets requested in this agreement expressly for means of extraction. Pseudonymised
[13 words unchanged]
Glasgow, and will not be shared with any organisation, including funding organisations.
[1 paragraph unchanged]
This study is funded by the British Heart Foundation with support from
[44 words unchanged]
Heart Foundation nor Pharmacosmos will have access to record-level data from NHS
Digital.
England.
As a result, neither organisation are considered a Data Controller or Data
[70 words unchanged]
from Pharmacosmos will be acknowledged in any publications related to the study.
NHS Digital is content that the
The
purpose of this study is to assess whether the addition of IV
[8 words unchanged]
(CHF) reduces morbidity and mortality in patients with iron deficiency and is
cost-effective, thus clearly demonstrating that the study
cost-effective and, therefore,
purpose is research into public health and
therefore providing
aiming to
benefit to health and social care in England. However, in the interests of
full
transparency, it is noted here that the results of this study may contribute towards commercial work
that results
resulting
in
indirect
financial benefit for
the funder
Pharmacosmos
which, in turn, may provide further funding for research into the population. If the study
provides
demonstrates
clear evidence of benefit of IV Iron treatment for heart failure patients then
Pharmacosmos may in future submit data from
the
results of the study may be submitted by the University of Glasgow
trial
to the
regulators of drugs
regulatory authorities
in the UK, European Union and elsewhere.
In this scenario, the recipient(s) would have no access to the participant identifier code/key and no data provided by NHS England would be shared with Pharmacosmos nor any other third party.
This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
IRONMAN trial ended in August 2022, however the long-term follow-up via record linkage is continuing as described in the trial protocol.
Processing activities
[1 paragraph unchanged]
Summary reports of serious adverse events are made to the Medicines and
[41 words unchanged]
into the study electronic Case Report Form. No records obtained from NHS
Digital
England
will be shared with regulatory agencies.
[6 paragraphs unchanged]
- Transfer of patient identifiers to NHS
Digital
England
and receipt of record-level pseudonymised data from NHS
Digital
England
[3 paragraphs unchanged]
1. The Robertson Centre will provide NHS
Digital
England
with the following identifiable data for the 1,400 consented study participants: NHS
[38 words unchanged]
either date of extract or date of withdrawal, where applicable) via NHS
Digital’s
England’s
Secure Electronic File Transfer Service (SEFT).
2. NHS
Digital
England
will link and extract the requested data and return the pseudonymised data files with the study ID only to the University of Glasgow via SEFT.
[1 paragraph unchanged]
Analyses based on data linkages carried out after the end of trial
[34 words unchanged]
from these analyses will be subject to disclosure control. No record-level NHS
Digital
England
data will be forwarded to regulatory authorities. Identifiable record-level data is kept in a separate secure section of the Robertson Centre’s secured work environment to the pseudonymised NHS
Digital
England
record-level data.
[8 paragraphs unchanged]
Expected measurable benefits
[3 paragraphs unchanged]
The study team believes that it is very important that they capture all deaths, hospitalisations and cancers, and the NHS
Digital
England
record-level pseudonymised data
requested in the agreement
will help them to achieve this objective.
Benefits reported
The initial linkage has identified a number of previously unreported clinical events. [28 words unchanged] follow-up in the trial as is likely to identify additional unreported events. It will provide validation of record linkage for identifying cardiovascular deaths and heart failure hospital admissions. This could simplify and reduce the cost of future clinical trials in heart failure.
Unchanged: Expected output.
DARS-NIC-433923-Z0V8D-v1.2 12 May 2022 to 31 January 2025
- Title
- Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)'
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 3
- Files released
- 4
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC)
What changed from DARS-NIC-433923-Z0V8D-v0.17
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2022-05-12 |
Benefits reported
Yielded Benefits is not a requirement for new applications.
The initial linkage has identified a number of previously unreported clinical events. Hence, the linkage is very important for accurate reporting of the results of the clinical trial. The additional linkage will provide more complete coverage of the period of follow-up in the trial as is likely to identify additional unreported events.
Unchanged: Objective for processing, Processing activities, Expected output, Expected measurable benefits.
Objective for processing
IRONMAN (Effectiveness of IntRavenous irON treatMent vs standard care in pAtieNts with heart failure and iron deficiency) is a randomised trial of Intravenous (IV) iron involving 1400 study participants with heart failure and iron deficiency in England and Wales, powered to detect effects on morbidity, mortality and cost-effectiveness that will inform clinical management and international guidelines. The Trial is being run by researchers in the Robertson Centre for Biostatistics (RCB) at the University of Glasgow
The trial will look at whether there is evidence that the addition of IV iron to standard care is of benefit. It is an investigator-designed and initiated study. It will utilise a PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) design. That is, the participants will be randomised to normal care or intravenous iron therapy with the participants and their physicians being aware of the treatment received. The study outcomes will be reviewed and adjudicated by an expert group who have no access to the randomisation arm the participants have been allocated to. Participants will be assigned to receive IV iron or not, in addition to guideline-indicated care. Participants assigned to IV iron will receive repeated doses sufficient to ensure iron repletion for the duration of the study. For participants consenting to collection of blood samples, samples will be stored for a biobank sub-study involving future analysis of biomarkers related to the progression of heart failure and patient outcomes. It is an event-driven trial, but it is expected that participants will be treated for between six months and 5.5 years. The study commenced in 2016 and is ongoing. Recruitment completed in October 2021 and the study follow up is expected to complete in March 2022. Long-term follow up will be for up to 10 years after recruitment ended.
Hospital Episode Statistics (HES) data will not include data for those treated at Welsh hospitals.
There was Public and Patient Involvement (PPI) in the trial design; the West Middlesex patient cardiomyopathy support group provided input and the draft protocol was reviewed by an independent heart failure service (Gloucestershire – heart failure nurse specialists and patients, coordinated by Head of Specialist Services). Full endorsement was given to the need for the study. There is also a patient representative on the Trial Steering Committee (TSC).
The pseudonymised record-level data requested from NHS Digital will allow the study researchers to obtain events (hospitalisations, cancers and deaths) in the year prior to the study participant's consent date, during study participation and up to ten years after the study end. As this is a morbidity/mortality study, follow up for clinical events is critical.
The University of Glasgow relies on the following Articles for General Data Protection Regulations (GDPR) lawful basis for data processing. Article 6(1)(e) (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller)– The University of Glasgow are under a Royal Charter and NHS Digital are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described herein and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.
Additionally, as health data is a special category of personal data, Article 9(2)(j) (archiving in the public interest, scientific or historical research or statistical purposes). The data is required for research purposes meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The Data Protection Act 2018 Schedule 1 Part 1 states that when processing special category data under the condition relating to research, the condition is met when:
(a) 'necessary for archiving purposes, scientific or historical research purposes or statistical purposes'. As described above the data is considered necessary for the performance of the task
(b) 'carried out in accordance with Article 89(1) of the GDPR'. In accordance with this article, processing is subject to appropriate safeguards. These include:
i. The data will be pseudonymised prior to dissemination by NHS Digital to the data recipient;
ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s acceptance criteria (see sections 2 and 5b of this application for further details);
iii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection (see sections 5a, 5b and 8a of this application for further details);
(c) 'is in the public interest'. NHS Digital is content that the information set out in the Benefits section of the application evidences that the data processing will be in the public interest - This study could result in a change to treatment guidelines in the way patients with heart failure are treated – therefore demonstrating that the processing is in the public interest. Data linkage will provide a more complete and objective record of study events than is otherwise available from local records.
The requested data are record level pseudonymised Cancer Registration data, Civil Registration (Deaths) data, and Hospital Episode Statistics (HES) – Admitted Patient Care (APC).
In terms of data minimisation, the study team are only requesting NHS Digital data necessary to detect study serious adverse events, potential endpoints and primary and secondary outcomes linked to 1,400 IRONMAN consented patients from one year prior to date of consent and up to ten years after study end. Clinical trials are required to collect data on Serious Adverse Events that include hospital admissions, deaths, and cancers.
The project has minimised the data requested for the consented population to those data elements needed to address the research questions and only access to pseudonymised data for up to one year prior to consent is requested. The study team have limited the fields to only those requested to fulfil the study analysis. Pseudonymised record-level patient data will be held on the Robertson Centre for Biostatistics (RCB) Analytical Platform. More information on this platform can be found in section 5(b) below. The study researchers, who are substantive employees of the University of Glasgow, will link the NHS Digital record-level pseudonymised data to the data collected in the IRONMAN study using a numerical study pseudo-identifier only to study concordance of the different sources of information. There are no other ways to obtain these data.
The only record-level identifiable data linkage permitted under this agreement is the linkage of the cohort identifiers provided to NHS Digital by University of Glasgow (IRONMAN ID number, NHS number, date of birth, postcode and name) to the NHS Digital data sets requested in this agreement expressly for means of extraction. Pseudonymised record-level data will only be accessed by substantive employees of the University of Glasgow, and will not be shared with any organisation, including funding organisations.
University of Glasgow is the Data Controller who also processes data for the purposes of this agreement.
This study is funded by the British Heart Foundation with support from Pharmacosmos in terms of the investigational medicinal product (IMP)who also provide additional financial support. Neither the British Heart Foundation nor Pharmacosmos have a designated role or responsibility in trial design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results. Neither the British Heart Foundation nor Pharmacosmos will have access to record-level data from NHS Digital. As a result, neither organisation are considered a Data Controller or Data Processor. A representative from Pharmacosmos will be invited to attend Trial Steering Committee (TSC) meetings as an observer and non-voting member. All members of the TSC are allowed to speak at meetings and as Pharmacosmos provide the drug for this study and distribute to the study sites, their input into study drug supply and distribution is invaluable. Pharmacosmos have no influence in the design or conduct of the study. Support from Pharmacosmos will be acknowledged in any publications related to the study.
NHS Digital is content that the purpose of this study is to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in England. However, in the interests of full transparency, it is noted here that the results of this study may contribute towards commercial work that results in indirect financial benefit for the funder which, in turn, may provide further funding for research into the population. If the study provides clear evidence of benefit of IV Iron treatment for heart failure patients then the results of the study may be submitted by the University of Glasgow to the regulators of drugs in the UK, European Union and elsewhere. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
Expected output
All Outputs including data will be aggregated with small number suppressed as per the HES analysis guide.
Results are expected to be reported in a peer-reviewed journal and at major scientific and clinical meetings. This is expected in 2022.
The research team believe that the results of this study would be of interest to a high impact factor journal. The research team intend to organise press releases to coincide with the publication to promote knowledge mobilisation of the study results. The findings are expected to be presented at major cardiovascular scientific and clinical meetings (e.g. European Society of Cardiology or American Heart Association meetings.)
The research team intend to produce a non-technical summary of the results which will be sent to patients who participated in the trial, patient groups and cardiovascular charities. The University of Glasgow aims to release a press release in collaboration with the British Heart Foundation. The research team will also work to generate media coverage of the study results (in aggregated with small numbers suppressed format) and communicate these to the wider public. Target date 2022.
Outputs may also be shared with funders, but ownership and control of the outputs rests with the University of Glasgow.
All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
Benefits reported
The initial linkage has identified a number of previously unreported clinical events. Hence, the linkage is very important for accurate reporting of the results of the clinical trial. The additional linkage will provide more complete coverage of the period of follow-up in the trial as is likely to identify additional unreported events.
DARS-NIC-433923-Z0V8D-v0.17 1 February 2022 to 31 January 2025
- Title
- Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)'
- Commercial
- Yes
- Sublicensing
- No
- Datasets
- 3
- Files released
- 2
Datasets: Cancer Registration Data; Civil Registrations of Death; Hospital Episode Statistics Admitted Patient Care (HES APC)
Objective for processing
IRONMAN (Effectiveness of IntRavenous irON treatMent vs standard care in pAtieNts with heart failure and iron deficiency) is a randomised trial of Intravenous (IV) iron involving 1400 study participants with heart failure and iron deficiency in England and Wales, powered to detect effects on morbidity, mortality and cost-effectiveness that will inform clinical management and international guidelines. The Trial is being run by researchers in the Robertson Centre for Biostatistics (RCB) at the University of Glasgow
The trial will look at whether there is evidence that the addition of IV iron to standard care is of benefit. It is an investigator-designed and initiated study. It will utilise a PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) design. That is, the participants will be randomised to normal care or intravenous iron therapy with the participants and their physicians being aware of the treatment received. The study outcomes will be reviewed and adjudicated by an expert group who have no access to the randomisation arm the participants have been allocated to. Participants will be assigned to receive IV iron or not, in addition to guideline-indicated care. Participants assigned to IV iron will receive repeated doses sufficient to ensure iron repletion for the duration of the study. For participants consenting to collection of blood samples, samples will be stored for a biobank sub-study involving future analysis of biomarkers related to the progression of heart failure and patient outcomes. It is an event-driven trial, but it is expected that participants will be treated for between six months and 5.5 years. The study commenced in 2016 and is ongoing. Recruitment completed in October 2021 and the study follow up is expected to complete in March 2022. Long-term follow up will be for up to 10 years after recruitment ended.
Hospital Episode Statistics (HES) data will not include data for those treated at Welsh hospitals.
There was Public and Patient Involvement (PPI) in the trial design; the West Middlesex patient cardiomyopathy support group provided input and the draft protocol was reviewed by an independent heart failure service (Gloucestershire – heart failure nurse specialists and patients, coordinated by Head of Specialist Services). Full endorsement was given to the need for the study. There is also a patient representative on the Trial Steering Committee (TSC).
The pseudonymised record-level data requested from NHS Digital will allow the study researchers to obtain events (hospitalisations, cancers and deaths) in the year prior to the study participant's consent date, during study participation and up to ten years after the study end. As this is a morbidity/mortality study, follow up for clinical events is critical.
The University of Glasgow relies on the following Articles for General Data Protection Regulations (GDPR) lawful basis for data processing. Article 6(1)(e) (processing is necessary for the performance of a task in the public interest or in the exercise of official authority vested in the controller)– The University of Glasgow are under a Royal Charter and NHS Digital are satisfied that this request is appropriate, necessary and proportionate for the performance of the task described herein and that there is no other reasonable means for the data processor to achieve their purpose that is less intrusive to the data subjects.
Additionally, as health data is a special category of personal data, Article 9(2)(j) (archiving in the public interest, scientific or historical research or statistical purposes). The data is required for research purposes meeting the conditions in the DPA 2018 Schedule 1 Part 1 (4) - which GDPR Recital 52(2) determines is an appropriate derogation from the prohibition on processing special categories of personal data. The Data Protection Act 2018 Schedule 1 Part 1 states that when processing special category data under the condition relating to research, the condition is met when:
(a) 'necessary for archiving purposes, scientific or historical research purposes or statistical purposes'. As described above the data is considered necessary for the performance of the task
(b) 'carried out in accordance with Article 89(1) of the GDPR'. In accordance with this article, processing is subject to appropriate safeguards. These include:
i. The data will be pseudonymised prior to dissemination by NHS Digital to the data recipient;
ii. The data recipient’s technical and organisational measures to safeguard the data have been assessed and meet NHS Digital’s acceptance criteria (see sections 2 and 5b of this application for further details);
iii. The requested data has been assessed as proportionate to the aim pursued (see section 5a of this application for further details);
iv. Controls, data retention and processing activities have been assessed to ensure respect to the essence of the right to data protection (see sections 5a, 5b and 8a of this application for further details);
(c) 'is in the public interest'. NHS Digital is content that the information set out in the Benefits section of the application evidences that the data processing will be in the public interest - This study could result in a change to treatment guidelines in the way patients with heart failure are treated – therefore demonstrating that the processing is in the public interest. Data linkage will provide a more complete and objective record of study events than is otherwise available from local records.
The requested data are record level pseudonymised Cancer Registration data, Civil Registration (Deaths) data, and Hospital Episode Statistics (HES) – Admitted Patient Care (APC).
In terms of data minimisation, the study team are only requesting NHS Digital data necessary to detect study serious adverse events, potential endpoints and primary and secondary outcomes linked to 1,400 IRONMAN consented patients from one year prior to date of consent and up to ten years after study end. Clinical trials are required to collect data on Serious Adverse Events that include hospital admissions, deaths, and cancers.
The project has minimised the data requested for the consented population to those data elements needed to address the research questions and only access to pseudonymised data for up to one year prior to consent is requested. The study team have limited the fields to only those requested to fulfil the study analysis. Pseudonymised record-level patient data will be held on the Robertson Centre for Biostatistics (RCB) Analytical Platform. More information on this platform can be found in section 5(b) below. The study researchers, who are substantive employees of the University of Glasgow, will link the NHS Digital record-level pseudonymised data to the data collected in the IRONMAN study using a numerical study pseudo-identifier only to study concordance of the different sources of information. There are no other ways to obtain these data.
The only record-level identifiable data linkage permitted under this agreement is the linkage of the cohort identifiers provided to NHS Digital by University of Glasgow (IRONMAN ID number, NHS number, date of birth, postcode and name) to the NHS Digital data sets requested in this agreement expressly for means of extraction. Pseudonymised record-level data will only be accessed by substantive employees of the University of Glasgow, and will not be shared with any organisation, including funding organisations.
University of Glasgow is the Data Controller who also processes data for the purposes of this agreement.
This study is funded by the British Heart Foundation with support from Pharmacosmos in terms of the investigational medicinal product (IMP)who also provide additional financial support. Neither the British Heart Foundation nor Pharmacosmos have a designated role or responsibility in trial design, conduct, data analysis and interpretation, manuscript writing, and dissemination of results. Neither the British Heart Foundation nor Pharmacosmos will have access to record-level data from NHS Digital. As a result, neither organisation are considered a Data Controller or Data Processor. A representative from Pharmacosmos will be invited to attend Trial Steering Committee (TSC) meetings as an observer and non-voting member. All members of the TSC are allowed to speak at meetings and as Pharmacosmos provide the drug for this study and distribute to the study sites, their input into study drug supply and distribution is invaluable. Pharmacosmos have no influence in the design or conduct of the study. Support from Pharmacosmos will be acknowledged in any publications related to the study.
NHS Digital is content that the purpose of this study is to assess whether the addition of IV iron to guideline-indicated therapy for Chronic Heart Failure (CHF) reduces morbidity and mortality in patients with iron deficiency and is cost-effective, thus clearly demonstrating that the study purpose is research into public health and therefore providing benefit to health and social care in England. However, in the interests of full transparency, it is noted here that the results of this study may contribute towards commercial work that results in indirect financial benefit for the funder which, in turn, may provide further funding for research into the population. If the study provides clear evidence of benefit of IV Iron treatment for heart failure patients then the results of the study may be submitted by the University of Glasgow to the regulators of drugs in the UK, European Union and elsewhere. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
Expected output
All Outputs including data will be aggregated with small number suppressed as per the HES analysis guide.
Results are expected to be reported in a peer-reviewed journal and at major scientific and clinical meetings. This is expected in 2022.
The research team believe that the results of this study would be of interest to a high impact factor journal. The research team intend to organise press releases to coincide with the publication to promote knowledge mobilisation of the study results. The findings are expected to be presented at major cardiovascular scientific and clinical meetings (e.g. European Society of Cardiology or American Heart Association meetings.)
The research team intend to produce a non-technical summary of the results which will be sent to patients who participated in the trial, patient groups and cardiovascular charities. The University of Glasgow aims to release a press release in collaboration with the British Heart Foundation. The research team will also work to generate media coverage of the study results (in aggregated with small numbers suppressed format) and communicate these to the wider public. Target date 2022.
Outputs may also be shared with funders, but ownership and control of the outputs rests with the University of Glasgow.
All evidence resulting from the trial will be made available as required to regulators of drugs in the UK, European Union and elsewhere. If the study does provide clear evidence of benefit of IV iron treatment, a full submission of the results of the study to regulators could result in a change of labelling for the use of IV iron in the treatment of heart failure patients. This could benefit Pharmacosmos and could help to make the treatment available to patients in the UK and more widely.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
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March 2022 —
first listed. 1 version: DARS-NIC-433923-Z0V8D-v0.17
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June 2022
1 version added: DARS-NIC-433923-Z0V8D-v1.2
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April 2025
1 version added: DARS-NIC-433923-Z0V8D-v2.2
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-433923-Z0V8D, “Data linkage request for 'Effectiveness of Intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)'”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-433923-z0v8d/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-433923-Z0V8D to see the original rows.