CAPTURE-HFpEF: National Study of Identification and Phenotyping of Heart Failure With Preserved Ejection Fraction

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorHerlev and Gentofte Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • HFpEF Observational Measurements

    Other intervention

    Observational 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

No treatment groups listed

Trial outcomes

Primary outcomes

1

Early identification of HFpEF

Proportion (%) of individuals identified through the screening procedures outlined in the protocol among the target population.

Time frame
baseline, pre-intervention

Secondary outcomes

1

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).

Time frame
Up to 24 months
2

Barriers to participation

Reported reasons for non-participation categorized and presented as percentages among individuals declining participation.

Time frame
Up to 24 months
3

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.

Time frame
Up to 24 months
4

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.

Time frame
Up to 24 months

Other outcomes

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: