Heart Failure With Preserved Ejection Fraction (HFPEF)CPH-HFpEFNCT06685237
Copenhagen Heart Failure With Preserved Ejection Fraction
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by Tor Biering-Sørensen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 89 years
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFPEF)
- How many people
- 5,000 participants
- Where
- 1 siteDenmark
- Study dates
- 28 Feb 2025to 28 Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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).
Who may be able to join
- Residence in the Capital Region of Denmark
- Age ≥ 50 years
- At least two risk factors for HFpEF defined as any of the following (for age ≥ 60 years, only one):
- Hypertension
- Diabetes mellitus
- Chronic kidney disease
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- Atrial fibrillation
- BMI > 25 kg/m2
- Previous heart valve surgery
- Ischemic heart disease
- Obstructive sleep apnea
- Furosemide 40 mg
Who cannot join
- Age ≥ 90 years
- Prevalent HF
- Dementia
- Nursing home
- Amyloidosis
- Hemodialysis
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- Cancer diagnosed within the past 5 years (skin cancer not included)
- Prior solid organ transplantation
- Lung disease defined as any of the following:
- World Health Organization Group 1 pulmonary hypertension
- Chronic pulmonary embolism
- Lung fibrosis
- Chronic obstructive pulmonary disease (COPD)
- Home oxygen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital, Herlev and Gentofte Hospital
Hellerup, 2900
Camilla I Ottosen, MD, +4538674143, camilla.ikast.ottosen@regionh.dk
Sine H Christensen, MSc, sine.hoejlund.christensen@regionh.dk
About this study
Official title: CoPenhagen Heart Failure With Preserved Ejection Fraction (CPH-HFpEF)
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.
Read the detailed description
The study is a prospective, observational cohort study. Using risk factors for HFpEF, the Danish National Health Registries will be used to identify up to 5000 citizens with at least one risk factor for HFpEF relying on International Classification of Diseases, 10th revision (ICD-10), medication, and biochemistry. The investigators will only recruit patients from the Capital Region of Denmark. Participants will be recruited by sending recruitment letters to a secure electronic mailbox (eBoks) linked to the patients' social security numbers.
The purpose of this study is to evaluate the identification and screening procedures for HFpEF outlined in this protocol. Additionally, the investigators aim to gauge the willingness of identified Danish adults with risk factors for HFpEF to participate in the study and to identify and address any barriers to their involvement. Overall, the investigators expect the results of this study can be used to guide future initiatives aimed at improving the identification and enrollment of patients with HFpEF, particularly among vulnerable populations.
- Keywords
- Heart failure with preserved ejection fraction, HFpEF, Registry, Screening, Echocardiography, Questionnaire, NT-proBNP
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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.
Measured: From the end of the study until all analyses are completed (estimated to be from November 2025 to March 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start28 Feb 2025
- Primary completion28 Nov 2025 (estimated)
- Study completion28 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFPEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tor Biering-Sørensen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tor Biering-Sørensen, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685237
- Sponsor's protocol ID
- CPH-HFpEF
- Other IDs
- H-24022361
- Acronym
- CPH-HFpEF
- Status last verified
- Mar 2025
- First submitted
- 11 Nov 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Most data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CoPenhagen Heart Failure With Preserved Ejection Fraction (CPH-HFpEF)
- ClinicalTrials.gov ID
- NCT06685237
- Acronym / sponsor ID
- CPH-HFpEF / CPH-HFpEF
- Keywords
- Heart failure with preserved ejection fraction, HFpEF, Registry, Screening, Echocardiography, Questionnaire, NT-proBNP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Tor Biering-SørensenUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 28 Nov 2025 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a prospective, observational cohort study. Using risk factors for HFpEF, the Danish National Health Registries will be used to identify up to 5000 citizens with at least one risk factor for HFpEF relying on International Classification of Diseases, 10th revision (ICD-10), medication, and biochemistry. The investigators will only recruit patients from the Capital Region of Denmark. Participants will be recruited by sending recruitment letters to a secure electronic mailbox (eBoks) linked to the patients' social security numbers.
The purpose of this study is to evaluate the identification and screening procedures for HFpEF outlined in this protocol. Additionally, the investigators aim to gauge the willingness of identified Danish adults with risk factors for HFpEF to participate in the study and to identify and address any barriers to their involvement. Overall, the investigators expect the results of this study can be used to guide future initiatives aimed at improving the identification and enrollment of patients with HFpEF, particularly among vulnerable populations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (12 listed)
- Residence in the Capital Region of Denmark
- Age ≥ 50 years
- At least two risk factors for HFpEF defined as any of the following (for age ≥ 60 years, only one):
Key exclusion criteria (14 listed)
- Age ≥ 90 years
- Prevalent HF
- Dementia
- Nursing home
- Amyloidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective of this study is to pilot the identification and screening procedures outlined in this protocol.
Time frame: From the invitation date until the end of the study (approximately 12 months).
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 (%).
1 secondary outcome
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.
Time frame: From the end of the study until all analyses are completed (estimated to be from November 2025 to March 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: Yes. Most data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor-investigator in case of any inquiries.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Preserved Ejection Fraction (HFPEF), run by Tor Biering-Sørensen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla I Ottosen, MD (+4538674143, camilla.ikast.ottosen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to pilot the identification and screening procedures outlined in this protocol. (time frame: From the invitation date until the end of the study (approximately 12 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.