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Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension (HYPER-endoEV-c)

22. juli 2026 opdateret af: Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek

Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension

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.

Studieoversigt

Status

Rekruttering

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

80

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plasma endothelial extracellular vesicle concentration
Tidsramme: Baseline
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Post-occlusive reactive hyperemia (PORH)
Tidsramme: Baseline
Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Baseline
Acetylcholine-induced vasodilation (AChID)
Tidsramme: Baseline
Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Baseline
Sodium nitroprusside-induced vasodilation (SNPID)
Tidsramme: Baseline
Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
Baseline
VCAM-1 concentration
Tidsramme: Baseline
Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
Baseline
ICAM-1 concentration
Tidsramme: Baseline
Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.
Baseline
Endocan concentration
Tidsramme: Baseline
Plasma endocan concentration measured as a marker of endothelial dysfunction.
Baseline
von Willebrand factor (vWF)
Tidsramme: Baseline
Plasma von Willebrand factor concentration measured as a marker of endothelial injury.
Baseline
Matrix metalloproteinase-9 (MMP-9)
Tidsramme: Baseline
Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Josip Juraj Strossmayer University of Osijek

Samarbejdspartnere

Osijek University Hospital

Efterforskere

  • Studiestol: Ivana Jukić, MD, PhD, Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. april 2026

Primær færdiggørelse (Anslået)

30. april 2029

Studieafslutning (Anslået)

30. september 2029

Datoer for studieregistrering

Først indsendt

22. juli 2026

Først indsendt, der opfyldte QC-kriterier

22. juli 2026

Først opslået (Faktiske)

27. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HYPER-endoEV-children

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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