Impact of renal impairment on immediate and long-term outcomes in acute heart failure patients in England over the last 15 years (23 NHFA 01)..

St George’s University Hospitals NHS Foundation Trust requires access to NHS England data for the purpose of the following service evaluation/research project:

Impact of renal impairment on immediate and long-term outcomes in acute heart failure patients in England over the last 15 years (23 NHFA 01).

Renal impairment (kidney failure), both acute and chronic, is a significant independent predictor of poor clinical outcomes in patients hospitalised with acute heart failure. Its presence is often linked to reduced adherence to guideline-directed medical therapy during the inpatient stay, largely due to the complex and reciprocal relationship between heart and renal disease. Despite its short-term impact being well recognised, the long-term effects of renal impairment on outcomes such as mortality and rehospitalisation remain poorly understood and under-researched.

The following is a summary of the aims of the service evaluation/research provided on behalf of St George’s University Hospitals NHS Foundation Trust:

1. To characterise patients with renal impairment at varying degrees of severity among those hospitalised with heart failure. This includes identifying potential explanatory variables such as:

• Demographics: age, gender, ethnicity, age at diagnosis, and BMI

• Comorbidities: including diabetes, hypertension, and family history of heart disease

• Routinely collected laboratory markers such as electrolytes, haemoglobin, troponin, and B-type Natriuretic Peptide (BNP)

• Adherence to guideline-directed heart failure therapies and diuretic use at both admission and discharge

2. To assess the impact of renal impairment, and its severity, on clinical outcomes in patients admitted with heart failure. Specific outcomes to be assessed include:

• Mortality: in-hospital death, 30-day mortality, and 1-year mortality.

• All-cause admissions, re-admissions and length of stay.

• Re-hospitalisation rates and time to re-hospitalisation.

• Overall survival: long-term survival rates in this patient population.

• Prescription patterns and dosages of guideline-directed heart failure therapies at admission and discharge, particularly in patients with reduced ejection fraction.

• The implications of prescription and dosages of diuretics on admission and discharge in this hospital population.

• Impact on imaging parameters such as echocardiographic parameters (heart failure with reduced, moderately reduced, or preserved ejection fraction.

3. To explore the extent to which the variables associated with renal impairment, and its severity, confound the effect of renal impairment on the clinical outcomes listed in objective 2.

4. To investigate the impact of guideline directed medical therapy and dose of diuretics on the clinical outcomes listed in objective 2. This is in patients admitted with acute heart failure, with or without renal impairment.

5. To determine the impact of blood pressure (including systolic blood pressure, diastolic blood pressure, and pulse pressure) at admission and discharge on the clinical outcomes listed in objective 2.

6. To develop a risk prediction tool for adverse outcomes in patients with acute heart failure, including hospital readmission and mortality (in-hospital, 30-day, 1-year, and overall survival). The tool will also assess the extent to which these outcomes are influenced by the presence and severity of renal impairment.

The study objectives based on the aggregated data include:

To examine annual - and where feasible, monthly - tends over the past 15 years in the clinical characteristics and management of inpatients admitted with acute heart failure, stratified by the presence and severity of renal impairment. Key outcomes to be assessed include, but are not limited to:

• Age-standardized in-hospital mortality

• All cause hospital admission and re-admissions

• 30-day mortality.

• Clinical adherence to guideline directed heart failure medical therapy and diuretics on admission and discharge in this hospital population.

The following NHS England Data will be accessed:

• NICOR National Heart Failure Audit database – necessary because this will help to identify the target sample (all patients in England with a diagnosis of heart failure).

• Hospital Episode Statistics (HES) Admitted Patient Care (APC) – necessary because this will help to determine the frequency that these patients are admitted to hospital. This data will also help identify which of these patients have renal impairment.

• Civil Registration of Deaths dataset – necessary because mortality is high among patients with heart failure and this dataset will provide patients date of birth and date of death.

The level of the Data will be pseudonymised.

The Data will be minimised as follows:

• Limited to a study cohort identified by NICOR as meeting the following criteria: Include all adult patients with heart failure recorded in the NICOR National Heart Failure Audit (NHFA) from 01/01/2007 to 31/07/2023.

St George’s University Hospitals NHS Foundation Trust is the sponsor and controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest due to the rising prevalence of heart failure and chronic kidney disease. They are two frequently coexisting conditions associated with significant morbidity, including hospitalisation and mortality. St George’s Hospital operates a joint cardiorenal clinic, where cardiologists and nephrologists collaborate to deliver integrated care for affected patients. The data will support identification of the additional challenges faced by individuals with both conditions and inform service development, resource allocation, and care delivery within the hospital.

The funding is provided by Kathleen Valles Charitable Trust. The funding is specifically for the project described.

St George’s University Hospitals NHS Foundation Trust is the sole controller who will also process the data.

A Patient and Public Involvement and Engagement (PPIE) group will contribute to refining the research methods and objectives. A plain language summary outlining the purpose of accessing the dataset has been prepared and will be distributed to a random selection of inpatients at the hospital to gather feedback. Patients will be invited to comment on four key areas: the perceived importance of the service evaluation, its acceptability, any suggested changes, and any additional remarks.

The summary will be shared with a minimum of 10 patients in the Acute Medical Unit (AMU) at St George’s Hospital. It will also be provided to two charities - Pumping Marvellous and Kidney Research U, both of which have previously supported PPIE activities and contributed to earlier projects and grant applications.

This project was reviewed and supported by the NICOR Research Access Committee (RAC) on 12/01/2024.

NHS England will provide the relevant records from the Civil Registrations of Death dataset and Hospital Episode Statistics Admitted Patient Care (HES APC) to St George’s University Hospitals NHS Foundation Trust. The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be stored on servers at St George’s University Hospitals NHS Foundation Trust.

St Georges Hospital NHS Foundation Trust stores data backup on the Cloud provided by St Georges Hospital NHS Foundation Trust

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

The Data will not leave England/Wales at any time.

Access is restricted to employees of St George’s University Hospitals NHS Foundation Trust who have authorisation from the Principal Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Researchers from St George’s University Hospitals NHS Foundation Trust will process the Data for the purposes described above.

The expected outputs of the processing will be:

• A report of findings to clinical teams at St George’s Hospital, including nephrologists, cardiologists, and cardiorenal specialists. These insights will help identify potential inequalities in service provision and inform strategic decisions around resource allocation and funding within the cardiorenal service. Anticipated by mid-2026.

• A report of findings to partner charities, including Pumping Marvellous and Kidney Research UK, both of which have previously supported patient and public involvement and engagement (PPIE) activities. These reports will highlight the relevance and impact of the research on patient communities represented by these organisations.

• Submissions to peer reviewed journals including the American Journal of Nephrology, Cardiorenal Medicine, Clinical Kidney Journal, and BMC Nephrology, with a projected minimum of five full-length publications within the first three years.

• Presentations including abstracts submitted to leading conferences in renal and cardiovascular medicine, including the World Congress of Nephrology (WCN) and UK Kidney Week. Full-length publications are anticipated by the end of 2026.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

• Research outputs will be presented locally at St George’s Hospital.

• Findings will be shared in governance meetings to highlight potential inequalities in services provided to patients with chronic kidney disease and heart failure.

• Insights will inform optimisation of funding and resource allocation within the cardiorenal service.

• Abstracts will be submitted to relevant conferences, including the World Congress of Nephrology and UK Kidney Week.

• Abstracts and publications will be disseminated via social media platforms such as ResearchGate and Twitter.

The target dates for outputs are from mid 2026-2027.

The findings will inform local decision-making by engaging healthcare leaders and policy makers, leading to service improvements that directly benefit patients with heart failure and chronic kidney disease.

- Insights derived from the dataset will support the identification of healthcare inequalities and clinical challenges specific to the patient population at St George’s Hospital, which contributes to the National Heart Failure Audit (NHFA).

- Utilising a large-scale dataset enhances the robustness of conclusions, enabling more comprehensive analysis than would be possible with smaller sample sizes.

- Dissemination of results through high-quality, peer-reviewed journals will contribute to the wider research community by highlighting gaps in the literature and advancing clinical understanding.

- The service evaluation/research will help shape future studies and interventions aimed at improving outcomes for individuals living with heart failure and chronic kidney disease.

The anticipated benefits outlined above are expected to positively impact patients over a multi-year timeframe, recognising that changes to clinical guidelines and healthcare policy require time to implement. In parallel, a risk assessment tool is being developed to predict the likelihood of hospitalisation in individuals with heart failure and chronic kidney disease. By incorporating variables such as demographics, comorbidities, and medication profiles, the tool aims to provide a quantifiable, objective measure of future risk. Following validation, the tool will be introduced within cardiorenal clinics to support clinical decision-making and patient education. This innovative approach is designed to empower patients with clearer insight into their health risks and promote informed choices that may reduce the likelihood of adverse outcomes.

The proposed outputs are expected to deliver meaningful public benefit at a local level through the timely implementation of policy changes that address the needs of patients with heart failure and chronic kidney disease, as identified within the dataset. These changes are anticipated within a matter of months, supported by the presentation of findings at local governance meetings and the dissemination of insights to clinical teams involved in patient care.

Additional benefit will be achieved through the introduction of a personalised risk assessment tool, designed to support individualised care for patients with heart failure and renal impairment in clinical settings such as outpatient clinics.

Longer-term impact will be realised through the publication of abstracts and peer-reviewed articles, contributing to the wider evidence base and advancing research in the fields of heart failure and chronic kidney disease. This dissemination will help inform future studies, clinical practice, and policy development at both national and international levels.

The potential benefits of the data will be communicated through multiple channels, including local patient engagement, social media platforms, academic conferences, and peer-reviewed journals. To further extend the reach and relevance of the work, ongoing collaboration will be maintained with two key charity partners—Pumping Marvellous and Kidney Research UK—both of which have played a vital role in previous Patient and Public Involvement and Engagement (PPIE) initiatives. These organisations will contribute to identifying specific challenges faced by their communities and help ensure that the research outputs address real-world needs. Findings will be shared directly with both charities, and they will also support the development of a plain language summary to facilitate broader public understanding and engagement.

Yielded Benefits is not a requirement for new applications.