Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension

NCT07728643 | Recruiting

• 1 other identifier: HYPER-endoEV-children
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Childhood hypertension is associated with early endothelial dysfunction and an increased risk of future cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their role in pediatric hypertension remains poorly understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive children and children with newly diagnosed, untreated primary hypertension. The study will also investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and circulating biomarkers of endothelial activation. The findings may improve understanding of endothelial injury in pediatric hypertension and support the development of non-invasive biomarkers for early cardiovascular risk assessment.

Conditions

Pediatric Hypertension; Endothelial Dysfunction; Primary Hypertension

Keywords

Pediatric Hypertension; Childhood Hypertension; Primary Hypertension; Endothelial Extracellular Vesicles; Endothelial Dysfunction; Endothelial Activation; Biomarkers; Microvascular Function; Laser Doppler Flowmetry; Cardiovascular Risk

Outcome Measures

Primary Outcomes (1)

• Plasma endothelial extracellular vesicle concentration

  Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

  Baseline

Secondary Outcomes (8)

• Post-occlusive reactive hyperemia (PORH)

  Baseline

• Acetylcholine-induced vasodilation (AChID)

  Baseline

• Sodium nitroprusside-induced vasodilation (SNPID)

  Baseline

• VCAM-1 concentration

  Baseline

• ICAM-1 concentration

  Baseline

Study Arms (2)

Normotensive Controls

Children and adolescents with normal blood pressure according to current pediatric hypertension guidelines.

Newly Diagnosed Untreated Primary Hypertension

Children and adolescents with newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include children and adolescents recruited from the outpatient clinics of the Department of Pediatrics, University Hospital Centre Osijek, Croatia. Participants will comprise normotensive children and adolescents and those with newly diagnosed, previously untreated primary hypertension, classified according to current pediatric hypertension guidelines.

You may qualify if:

• Children and adolescents aged 6-17 years.
• Written informed consent from a parent or legal guardian and assent from the participant when appropriate.
• Normotensive status or newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines.
• Ability to comply with study procedures.

You may not qualify if:

• Secondary hypertension.
• Previous antihypertensive treatment.
• Congenital heart disease or other significant cardiovascular disease.
• Diabetes mellitus.
• Chronic kidney disease.
• Autoimmune or chronic inflammatory disease.
• Acute infection at the time of enrollment.
• Malignancy.
• Use of medications known to affect endothelial function.
• Inability to comply with study procedures.

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• Osijek University Hospital: collaborator

Study Sites (1)

Faculty of Medicine Osijek

Osijek, 31000, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples will be collected from all participants by standard peripheral venipuncture. Blood samples will be processed to obtain plasma, which will be stored at -80°C for the isolation and quantification of endothelial extracellular vesicles and the analysis of circulating biomarkers of endothelial function.

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ivana Jukić, MD, PhD

  Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

  STUDY CHAIR

Central Study Contacts

Ivana Jukić, MD, PhD

CONTACT

+38531512800; medicina@mefos.hr

Ana Stupin, MD, PhD

CONTACT

+38531512800; medicina@mefos.hr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor Tenure, Head of the Department of Physiology and Immunology, Faculty of Medicine Osijek

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)