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Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy

Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07728656
Acronym
HYPER-endoEV-p
Enrollment
80
Registered
2026-07-27
Start date
2026-04-01
Completion date
2029-09-30
Last updated
2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Hypertension, Hypertensive Disorder of Pregnancy, Preeclampsia

Keywords

Hypertensive Disorders of Pregnancy, Gestational Hypertension, Preeclampsia, Pregnancy, Endothelial Dysfunction, Endothelial Extracellular Vesicles, Extracellular Vesicles, Endothelial Activation, Biomarkers, Microvascular Function, Laser Doppler Flowmetry, Cardiovascular Risk

Brief summary

Hypertensive disorders of pregnancy are associated with endothelial dysfunction and increased maternal and fetal morbidity. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their relationship with blood pressure and endothelial function during pregnancy remains incompletely understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive pregnant women and pregnant women with hypertensive disorders of pregnancy. 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 during pregnancy and support the development of non-invasive biomarkers for early detection and monitoring of hypertensive disorders of pregnancy.

Interventions

None listed

Sponsors

Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER
Osijek University Hospital
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Pregnant women aged ≥18 years. * Singleton pregnancy. * Ability to provide written informed consent. * Normotensive pregnancy or diagnosis of gestational hypertension or preeclampsia according to current clinical guidelines. * Ability to comply with study procedures.

Exclusion criteria

* Chronic hypertension diagnosed before pregnancy. * Multiple pregnancy. * Pre-existing diabetes mellitus. * Chronic kidney disease. * Autoimmune disease. * Known cardiovascular disease. * Active infection or inflammatory disease. * Malignancy. * Inability or unwillingness to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Plasma endothelial extracellular vesicle concentrationBaselineConcentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.

Secondary

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

Countries

Croatia

Contacts

CONTACTMartina Vulin, MD, PhD
martina.vulin@mefos.hr+38531512302
CONTACTAna Stupin, MD, PhD
ana.stupin@mefos.hr+38531512800
STUDY_CHAIRAna Stupin, MD, PhD

Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026