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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorJosip Juraj Strossmayer University of Osijek

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Secondary hypertension.

Previous antihypertensive treatment.

Congenital heart disease or other significant cardiovascular disease.

Diabetes mellitus.

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 2 trial groups
Group A: Normotensive Controls
Group B: Newly Diagnosed Untreated Primary Hypertension

Trial outcomes

Primary outcomes

1

Plasma endothelial extracellular vesicle concentration

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

Time frame
Baseline

Secondary outcomes

1

Post-occlusive reactive hyperemia (PORH)

Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.

Time frame
Baseline
2

Acetylcholine-induced vasodilation (AChID)

Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.

Time frame
Baseline
3

Sodium nitroprusside-induced vasodilation (SNPID)

Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.

Time frame
Baseline
4

VCAM-1 concentration

Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Josip Juraj Strossmayer University of Osijek

Lead sponsor

Osijek University Hospital

Collaborator