Despite death rates from diseases relating to heart and blood vessels as a whole having declined, heart failure (HF) is both common and increasing in nearly all regions and represents a growing health problem that will reach epidemic proportions in an ageing and rapidly expanding global population. The lifetime risk for developing HF is 20% for both men and women and approximately one-half of HF patients have a decrease in heart pump function (reduced ejection fraction). Patients with worsening heart failure and reduced ejection fraction (HFrEF) have a higher risk of death (50% death rate within 5 years of diagnosis) and illness despite the use of standard-of-care therapy as indicated by the need for hospitalization or the use of loop diuretics (without hospitalisation). Due to the high risk of adverse outcomes (hospitalisation and death), HF is associated with a lower health-related quality of life as well as a higher healthcare resource utilisation. Despite in the last decade the advances in pharmacological and intracardiac device-based therapies (implantable cardioverter defibrillators and pacemakers) triggered a reduction in mortality rates, HF remain as malignant as some common cancers and imposes a huge global economic burden, estimated at $108 billion per annum. The specific aim of this observational cohort analysis is to better understand the epidemiology, demographic and clinical characteristics, treatment patterns, and outcomes in patients with HFrEF who develop worsening HFrEF. Additionally, this study will help to contextualise findings from a particular clinical trial.
The study population will be determined using events from both primary care and linked data sources (HES and ONS). In addition to providing information on healthcare resource use, the HES data will be used to assess baseline comorbidity burden and to determine outcomes. Data from ONS will be used to get information on date and cause of death.
A population-based cohort, including all the patients meeting minimum age and data quality requirements, will be used to calculate the incidence and prevalence of HF, HFrEF and HFpEF for each year between 2008 and 2018.
The HFrEF cohort represented by patients with HFrEF will be followed from the time of incident HFrEF diagnosis (index date) until the first of the following events: disenrollment from practice or from CPRD, death, end of the study period or occurrence of the respective outcome.
In a further analysis, all outcomes will be assessed: from index date to first worsening event (i.e. HF hospitalisation), from 1st to 2nd, from 2nd to 3rd, from 3rd to 4th and from 4th to 5th worsening event.
Finally, a worsening HFrEF cohort with three mutually exclusive subpopulations will be selected to assess the generalizability of the clinical trial.
Descriptive statistics will be calculated using the denominator with non-missing values. Incidence rate of clinical outcomes, HF-related complications and safety outcomes will be calculated per 10,000 person-years. 95% confidence intervals (95% CI) will be estimated using a Poisson distribution. For the HFrEF and the worsening cohort, incidence rates will be calculated over the study period as well as yearly. The risk and 95% CI for individual complications of HFrEF will be estimated using Kaplan-Meier estimators. For the inpatient/outpatient encounters, we will estimate an HRU rate per 100 person-years for each measure and the 95% CI using a Poisson distribution.
- Incidence and prevalence of HF, HFrEF and preserved ejection fraction (HFpEF) in a UK population-based cohort, including all the patients meeting minimum age of 18 years and data quality requirements
- Drug treatment patterns in patients with HFrEF
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Jennifer Quint - Chief Investigator - Imperial College London
Laura Portas - Corresponding Applicant - Imperial College London
- Collaborator -
Anina Fraschke - Collaborator - Bayer AG
Bernard Wilson - Collaborator - Bayer AG
Niklas Schmedt - Collaborator - Bayer AG
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation