Heart failure (HF) is an important and serious problem both in patients with and without type 2 diabetes (T2D). In a time of emerging treatment options that may offer benefits to patients with HF, there is an increasing need to understand the size of the problem, characteristics of patients affected and the impact of the choice of medications used to treat these patients in clinical practice. Work to date include clinical trial studies in patients with and without diabetes who already have established heart and blood vessel diseases. The results from the studies are very encouraging and show the treatment reduced the progression of HF. However, as only limited number of people can be enrolled in trials due to the rigorous selection criteria, the findings may not be generalised across all populations. There are very few contemporary reports on the characteristics and outcomes of HF that have investigated specific subgroup populations, particularly people whose heart in not able to pump enough blood in each heartbeat. In addition, the role of new therapies that may offer benefits to patients to patients with HF is yet to be explored, including treatment adherence and how the disease progression may increase risks of adverse complications, death and healthcare cost in these patients. Therefore, this study will use administrative healthcare records to describe populations of patients with HF in order to understand the disease burden and their association with adverse clinical outcomes and death.
Using a cohort of patients with heart failure, we will describe and compare the characteristics of heart failure patients over time, including the epidemiology of HF in various subgroup populations and patterns of adverse complications. This study will utilise both CPRD Aurum and CPRD GOLD database and the study period will begin on 1 January 2007 and will end on 30 September 2019. Each of the clinical outcomes of interest will be described separately. Event rates and 95% CIs will be reported as both incidence risks and incidence rates. Survival distributions utilising Kaplan-Meir method will describe time to cardiovascular (CV) or renal disease progression, time to CV- and all-cause mortality. Relative risks and risk factors associated with outcomes will be estimated using Cox proportional hazard models. In addition, we aim to further evaluate the care pathways of the patients to describe health resource use including GP consultations, laboratory tests or measurements, medication, referrals to specialist and hospital admissions. Such evidence will be used to highlight any unmet treatment needs and inform the current literature gap in this area.
The study outcomes are aligned to the core objectives of this study and described below.
Primary objective: Cardiovascular, renal outcomes and metabolic outcomes
Primary outcomes include composite and individual components of specific hospitalisations for heart failure (HF), myocardial infarction (MI), stroke, peripheral artery disease (PAD), renal outcomes (including hospitalisation for kidney disease and end-stage renal disease [ESRD]), cardiovascular and all-cause death, and their associated risk factors. Other outcomes include, percutaneous coronary interventions, coronary artery bypass graft surgery, heart transplant surgery.
Secondary objective: Health care cost of heart failure
Secondary outcomes include monetised costs of health care resource use; resources include disease management services in the clinical guideline, e.g., GP consultations, laboratory tests, medications and hospitalisations. Others include urgent care visits, emergency department attendances, heart transplant surgery and devices.
Jil Billy Mamza - Chief Investigator - AstraZeneca Ltd - UK Headquarters
He Gao - Corresponding Applicant - AstraZeneca Ltd - UK Headquarters
Amitava Banerjee - Collaborator - University College London ( UCL )
Andrew Coats - Collaborator - University of Warwick
Cathy Emmas - Collaborator - AstraZeneca Ltd - UK Headquarters
Christen Gray - Collaborator - AstraZeneca Ltd - UK Headquarters
Corinna (Lai San) Hong - Collaborator - AstraZeneca Ltd - UK Headquarters
Eleni Rapsomaniki - Collaborator - AstraZeneca Ltd - UK Headquarters
Gengshi Chen - Collaborator - AstraZeneca Ltd - UK Headquarters
George Godfrey - Collaborator - AstraZeneca Ltd - UK Headquarters
He Gao - Collaborator - AstraZeneca Ltd - UK Headquarters
Jiji Nair - Collaborator - Astra Zeneca Inc - USA
Johan Bodegård - Collaborator - Astra Zeneca Inc - USA
Jun Zou - Collaborator - Astra Zeneca Inc - USA
Manish Tripathi - Collaborator - Astra Zeneca Inc - USA
Martin Cowie - Collaborator - Imperial College London
Phillip Hunt - Collaborator - Astra Zeneca Inc - USA
Ping Sun - Collaborator - AstraZeneca Ltd - UK Headquarters
Ruiqi Zhang - Collaborator - AstraZeneca Ltd - UK Headquarters
Senthil Periaswamy - Collaborator - Astra Zeneca Inc - USA
Supriya Kumar - Collaborator - AstraZeneca Ltd - UK Headquarters
Tamsin Morris - Collaborator - AstraZeneca Ltd - UK Headquarters
Xiaojian Chen - Collaborator - Astra Zeneca Inc - USA
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation