Copenhagen Heart Failure with Preserved Ejection Fraction (CPH-HFpEF)

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure with Preserved Ejection Fraction (HFPEF)

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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Camilla I Ottosen, MD; Phone Number: +4538674143; Email: camilla.ikast.ottosen@regionh.dk
• Study Contact Backup: Name: Tor Biering-Sørensen, MD, MPH, MSc, PhD; Phone Number: +4528933590; Email: tor.biering@gmail.com

Study Locations

• Denmark
  • Hellerup, Denmark, 2900
    • Recruiting
    • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital, Herlev and Gentofte Hospital
    • Contact: Camilla I Ottosen, MD; Phone Number: +4538674143; Email: camilla.ikast.ottosen@regionh.dk
    • Contact: Sine H Christensen, MSc; Email: sine.hoejlund.christensen@regionh.dk
    • Contact: Tor Biering-Sørensen, MD, MPH, MSc, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

1. Residence in the Capital Region of Denmark
2. Age ≥ 50 years

3. 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
   • Atrial fibrillation
   • BMI > 25 kg/m2
   • Previous heart valve surgery
   • Ischemic heart disease
   • Obstructive sleep apnea
   • Furosemide 40 mg

Exclusion Criteria:

1. Age ≥ 90 years
2. Prevalent HF
3. Dementia
4. Nursing home
5. Amyloidosis
6. Hemodialysis
7. Cancer diagnosed within the past 5 years (skin cancer not included)
8. Prior solid organ transplantation

9. 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%).	From the invitation date until the end of the study (approximately 12 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the end of the study until all analyses are completed (estimated to be from November 2025 to March 2026

Collaborators and Investigators

• Sponsor: Tor Biering-Sørensen

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2025
• Primary Completion (Estimated): November 28, 2025
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Screening; Questionnaire; Registry; Echocardiography; Heart failure with preserved ejection fraction; HFpEF; NT-proBNP
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: CPH-HFpEF; H-24022361 (Other Identifier: De Videnskabsetiske Komitéer for Region Hovedstaden (VEK))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No