About this trial
Heart failure with preserved ejection fraction (HFpEF) has grown to become the dominant form of heart failure (HF) worldwide, in tandem with ageing of the general population and the increasing prevalence of obesity, diabetes mellitus and hypertension. In 2020, \> 70% of patients with heart failure had preserved ejection fraction. The incidence and prevalence of HFpEF has been growing by 10% every 10 years relative to HF with reduced ejection fraction (HFrEF). In 2017, the prevalence of HFpEF varied from 1% to 14% based on available data from Europe and USA. HFpEF is associated with high morbidity and mortality, and patients with HFpEF have similarly high hospitalization rates as patients with HFrEF. Hence, HFpEF poses a substantial global health challenge. Despite its prevalence, HFpEF remains undiagnosed and underrecognized, necessitating a comprehensive approach to both identification and management.
Ensuring successful treatment necessitates early identification of HFpEF. Consequently, a targeted screening strategy has been devised for the identification of HFpEF patients. Given the higher prevalence of heart failure (HF) in the elderly population, testing the screening strategy is imperative to customize it to the specific needs of vulnerable patients who may be more inclined to decline participation in the screening program.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Residence in the Capital Region of Denmark
Age ≥ 50 years
Hypertension
Diabetes mellitus
Disqualifiers
Age ≥ 90 years
Prevalent HF
Dementia
Nursing home
Trial population
5000 citizens aged 50 years or above in the Capital Region of Denmark with at least two risk factors for HFpEF (for age ≥ 60 years, only one).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
The primary objective of this study is to pilot the identification and screening procedures outlined in this protocol.
The primary objective of this study is to pilot the identification and screening procedures outlined in this protocol. This includes assessing the identification rate (%) and estimating the prevalence of heart failure with preserved ejection fraction (HFpEF) both overall and within different subgroups (%).
Secondary outcomes
Secondarily, we aim to assess the willingness of identified Danish adults with risk factors for HFpEF to participate in the study, as well as to identify and address any barriers to their involvement.
* To assess response, acceptance, and attendance rates among participants, reported as percentages. * To investigate barriers to participation, categorizing and presenting them as percentages. * To analyze patterns among non-responders, using educational attainment, household income, and geographic distances to the study site as indicators of socioeconomic and sociodemographic status. All parameters will be clustered and reported as percentages. Through these objectives, we aim to gain a comprehensive understanding of participant engagement and identify any factors that may hinder participation in the screening process.
Sponsors and contacts
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Tor Biering-Sørensen
Lead sponsor
Herlev and Gentofte Hospital
Sponsor institution