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

NCT07493590 | Not Yet Recruiting

• 1 other identifier: H-25050340
• Study Type: observational
• Target: 30,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heart Failure With Preserved Ejection Fraction (HFPEF)

Keywords

Heart failure; Heart Failure with Preserved Ejection Fraction (HFpEF); Cardiovascular Mortality; Cardiovascular Disease; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Early identification of HFpEF

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

  baseline, pre-intervention

Secondary Outcomes (5)

• Response, acceptance, and attendance rates

  Up to 24 months

• Barriers to participation

  Up to 24 months

• Patterns among non-responders

  Up to 24 months

• Prevalence of Heart failure with preserved ejection fraction in risk factor subgroups

  Up to 24 months

• Feasibility of the logistical screening setup

  Up to 24 months

Interventions

HFpEF Observational Measurements OTHER

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• Patients \>60 years with ≥1 risk factor, OR
• Patients \>50 years with ≥2 risk factors
• Hypertension
• Type 1 or 2 diabetes
• Chronic kidney disease (eGFR \<60 mL/min/1.73 m²)
• Previous cardiotoxic drug exposure
• atrial fibrillation
• Ischemic heart disease
• Previous heart valve surgery/intervention
• Body mass index \>30 kg/m² (self-reported)
• Use of ≥40 mg furosemide
• Obstructive sleep apnea
• Non-alcoholic fatty liver disease

You may not qualify if:

• Cancer \<1 year
• Dialysis
• COPD and O2
• Nursing home
• Age \>90 years
• Dementia
• Known dilated cardiomyopathy
• Prior organ-transplantation
• Amyloidosis

Sponsors & Collaborators

• Herlev and Gentofte Hospital: lead
• Aalborg University Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator
• Zealand University Hospital: collaborator

Study Sites (1)

Herlev and Gentofte Hospital

Copenhagen, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood (approximately 50 mL) will be collected and processed into plasma, serum, and whole blood fractions. Whole blood will be stored for potential DNA extraction. Samples will be retained in a regional biobank (BIOSEK) for up to 10 years for future genetic, -omics, and cardiovascular biomarker analyses. Furthermore, myocardial biopsies from a subset of participants will also be stored for later analysis.

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases

Study Officials

• Emil Wolsk, MD, PhD

  Department of Cardiology, Herlev and Gentofte Hospital, Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist Cardiologist

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 25, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2033
• Study Completion (Estimated): April 1, 2035
• Last Updated: March 25, 2026

Record last verified: 2026-03

Locations

DK (1)