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

NCT07728656 | Recruiting

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

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.

Conditions

Hypertensive Disorder of Pregnancy; Gestational Hypertension; 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

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 Pregnancy

Pregnant women with normal blood pressure and uncomplicated singleton pregnancy.

Hypertensive Disorders of Pregnancy

Pregnant women diagnosed with hypertensive disorders of pregnancy, including gestational hypertension or preeclampsia, according to current clinical guidelines.

Eligibility Criteria

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

Study Population

The study population will include pregnant women aged 18 years and older recruited from the outpatient clinics of the Department of Obstetrics and Gynecology, University Hospital Centre Osijek, Croatia. Participants will comprise normotensive pregnant women and women with newly diagnosed hypertensive disorders of pregnancy, including gestational hypertension and preeclampsia, diagnosed according to current international clinical guidelines.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Medicine Osijek

Osijek, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples will be collected from all participants. Plasma will be isolated and stored for subsequent analyses of endothelial extracellular vesicles and endothelial biomarkers.

MeSH Terms

Conditions

Toxemia; Hypertension, Pregnancy-Induced; Pre-Eclampsia

Condition Hierarchy (Ancestors)

Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Stupin, MD, PhD

  Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

  STUDY CHAIR

Central Study Contacts

Martina Vulin, MD, PhD

CONTACT

+38531512302; martina.vulin@mefos.hr

Ana Stupin, MD, PhD

CONTACT

+38531512800; ana.stupin@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 Proffesor Tenure, Head of 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: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)