Copenhagen Heart Failure With Preserved Ejection Fraction

NCT06685237 | Recruiting

• 2 other identifiers: CPH-HFpEFH-24022361
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart failure with preserved ejection fraction; HFpEF; Registry; Screening; Echocardiography; Questionnaire; NT-proBNP

Outcome Measures

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 (%).

  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.

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

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Age ≥ 90 years
• Prevalent HF
• Dementia
• Nursing home
• Amyloidosis
• Hemodialysis
• 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

Sponsors & Collaborators

• Tor Biering-Sørensen: lead

Study Sites (1)

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

Hellerup, 2900, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples.

Central Study Contacts

Camilla I Ottosen, MD

CONTACT

+4538674143; camilla.ikast.ottosen@regionh.dk

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

CONTACT

+4528933590; tor.biering@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: February 28, 2025
• Primary Completion: November 28, 2025
• Study Completion: March 28, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)