Copenhagen Heart Failure With Preserved Ejection Fraction

NCT ID: NCT06685237

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-28
• Study Completion Date: 2026-03-28

Brief 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. 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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tor Biering-Sørensen

OTHER

Sponsor Role: lead

Responsible Party

Tor Biering-Sørensen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital, Herlev and Gentofte Hospital

Hellerup, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Camilla I Ottosen, MD

Role: CONTACT

camilla.ikast.ottosen@regionh.dk

+4538674143

Tor Biering-Sørensen, MD, MPH, MSc, PhD

Role: CONTACT

tor.biering@gmail.com

+4528933590

Facility Contacts

Camilla I Ottosen, MD

Role: primary

camilla.ikast.ottosen@regionh.dk

+4538674143

Sine H Christensen, MSc

Role: backup

sine.hoejlund.christensen@regionh.dk

Other Identifiers

H-24022361

Identifier Type: OTHER

Identifier Source: secondary_id

CPH-HFpEF

Identifier Type: -

Identifier Source: org_study_id