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NCT Number: NCT07728656

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

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.

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Key information

Conditions

Hypertensive Disorder of Pregnancy Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Infections Pre-Eclampsia Preeclampsia Pregnancy Complications Toxemia Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Plasma endothelial extracellular vesicle concentration

    Time frame: Baseline

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

Secondary outcomes

  1. Post-occlusive reactive hyperemia (PORH)

    Time frame: Baseline

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

  2. Acetylcholine-induced vasodilation (AChID)

    Time frame: Baseline

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

  3. Sodium nitroprusside-induced vasodilation (SNPID)

    Time frame: Baseline

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

  4. VCAM-1 concentration

    Time frame: Baseline

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

  5. ICAM-1 concentration

    Time frame: Baseline

    Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.

  6. Endocan concentration

    Time frame: Baseline

    Plasma endocan concentration measured as a marker of endothelial dysfunction.

  7. von Willebrand factor (vWF)

    Time frame: Baseline

    Plasma von Willebrand factor concentration measured as a marker of endothelial injury.

  8. Matrix metalloproteinase-9 (MMP-9)

    Time frame: Baseline

    Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Stupin, MD, PhD

CONTACT

[email protected]

+38531512800

Martina Vulin, MD, PhD

CONTACT

[email protected]

+38531512302

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • Osijek University Hospital

Registry information

Official study title

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

Acronym: HYPER-endoEV-p

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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