Copenhagen Heart Failure With Preserved Ejection Fraction

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-89
SponsorTor Biering-Sørensen

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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 (%).

Time frame
From the invitation date until the end of the study (approximately 12 months).

Secondary outcomes

1

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.

Time frame
From the end of the study until all analyses are completed (estimated to be from November 2025 to March 2026

Other outcomes

Sponsors and contacts

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Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution