About this trial
The goal of this observational study is to improve early detection, characterization, and understanding of heart failure with preserved ejection fraction (HFpEF) in adults at risk of or diagnosed with HFpEF, including men and women across Danish regions.
The main questions to answer are:
Can systematic cardiovascular screening and deep phenotyping improve early identification and classification of HFpEF?
Which clinical, imaging, biomarker, and metabolic characteristics define subtypes (phenotypes) of HFpEF and predict disease progression and outcomes?
Researchers will compare participants with HFpEF, participants at risk of HFpEF, and relevant control groups to see if differences in biomarkers, imaging findings, and clinical characteristics can identify early disease stages and distinct HFpEF phenotypes.
Participants identified with HFpEF will:
* Undergo detailed cardiovascular examinations (e.g., echocardiography, CT and other imaging examinations, RHC, CPET) * Provide blood and tissue samples for biomarker and metabolic analyses * Complete clinical assessments and questionnaires * Have relevant health data collected from national health registries * Attend follow-up assessments to monitor disease progression
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients >60 years with ≥1 risk factor, OR
Patients >50 years with ≥2 risk factors
Hypertension
Type 1 or 2 diabetes
Disqualifiers
Cancer <1 year
Dialysis
COPD and O2
Nursing home
Trial population
Adult individuals across Denmark with risk factors for heart failure with preserved ejection fraction (HFpEF). Participants will be identified through nationwide registries and invited via the Danish secure e-mail system (e-Boks).
Trial design
Cohort
Prospective
Treatments tested in this trial
HFpEF Observational Measurements
Other interventionObservational measurements including collection of blood for biomarker and genetic analyses, echocardiography, ECG, and extraction of clinical data from electronic health records (comorbidities, medications, and prior hospitalizations). No treatment or procedure is assigned; all data reflect routine care and participant characteristics.
Treatment groups
Trial outcomes
Primary outcomes
Early identification of HFpEF
Proportion (%) of individuals identified through the screening procedures outlined in the protocol among the target population.
Secondary outcomes
Response, acceptance, and attendance rates
The proportion (%) of invited individuals who respond to the study invitation (response rate), the proportion (%) of responders who agree to participate (acceptance rate), and the proportion (%) of participants who attend the scheduled study visit (attendance rate).
Barriers to participation
Reported reasons for non-participation categorized and presented as percentages among individuals declining participation.
Patterns among non-responders
Distribution of non-responders based on educational attainment, household income, and geographic distance to the study site as indicators of socioeconomic and sociodemographic status, presented as percentages.
Prevalence of Heart failure with preserved ejection fraction in risk factor subgroups
Prevalence (%) of HFpEF among predefined risk factor subgroups, including individuals with diabetes, hypertension, and chronic kidney disease.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Herlev and Gentofte Hospital
Lead sponsor
Aalborg University Hospital
Collaborator
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
Zealand University Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options: