Investigate the determinants and trends of heart failure and other major cardiovascular events in diabetes patients and their subsequent prognosis within the UK population

Study type
Protocol
Date of Approval
Study reference ID
21_000355
Lay Summary

People with diabetes have an increased risk of heart failure, a condition where the heart is unable to pump enough blood around the body. Previous studies have shown that heart failure frequently follows a disease, affecting arteries of the heart, defined as ischaemic heart disease (e.g angina and myocardial infarction) and is characterised by a reduced amount of oxygen to the heart. Recent evidence suggests that a higher frequency of patients with diabetes could be presenting with heart failure without previous ischaemic heart disease. However, whether the risk of heart failure has changed over time, relative to myocardial infarction is unknown. Furthermore, whether there are differences by age, sex, ethnicity, and type of diabetes remains uncertain. The main aim of this study is to investigate the change over time in the incidence of heart failure compared to that of ischaemic heart disease in patients with diabetes. In addition, we will explore whether the incidence is related to prognostic factors such as age, sex, ethnicity, medications and other related. This research is necessary for aiding the development of more tailored prevention and management approaches for diabetes.

Technical Summary

Patients with diabetes have an increased risk of heart failure (HF). Most HF cases tend to present with prior diagnosis of ischaemic heart disease (IHD), such as myocardial infarction. However, in patients with and without diabetes there have been significant improvements in the treatment of risk factors associated with IHD, resulting in reducing trends in myocardial infarction. As such, a higher proportion of HF cases may have not been driven by IHD in the last years, by which glucose can directly affect HF without IHD. This is relevant since it is unknown whether this phenotype transition has occurred. Moreover, whether there are differences by risk factors or diabetes type remains unclear.
This study will use Clinical Practice Research Datalink (CPRD) data linked with Hospital Episode Statistics (HES) and Office for National Statistics (ONS) to investigate the associations between diabetes (type 1 and type 2 diabetes) and IHD and HF over time using Royston-Parmar survival models. In addition, we will explore if the risk factors age, sex, ethnicity, treatment, socio-economic status, and comorbidities have an impact on the incidence trajectories. We will investigate the hospitalisation and mortality risk in patients with a diagnosis of IHD or HF also using Royston-Parmar survival models. We will stratify HF by ischaemic vs. non-ischaemic HF to further explore whether trends have changed over-time.

Health Outcomes to be Measured

Using both CPRD and HES, the outcome heart failure, ischaemic heart failure and non-ischaemic heart failure will be compared to the outcome myocardial infarction and ischaemic heart disease (e.g unstable angina, stable angina, myocardial infarction or coronary bypass).

Collaborators

Francesco Zaccardi - Chief Investigator - University of Leicester
Kajal Panchal - Corresponding Applicant - University of Leicester
Claire Lawson - Collaborator - University of Leicester
Kamlesh Khunti - Collaborator - University of Leicester

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation