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RecruitingNCT07728656HYPER-endoEV-pUpdated Jul 27, 2026

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

An observational study in Hypertensive Disorder of Pregnancy, Gestational Hypertension and Preeclampsia, sponsored by Josip Juraj Strossmayer University of Osijek. Recruiting at 1 site in Croatia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-27.

Primary conditionPre-EclampsiaRegistry: Hypertension, Pregnancy-InducedReclassifiedWhy we changed it
Registry
Hypertension, Pregnancy-Induced — the first condition term the registry derived for this study.
ClinicalTrials.gg
Pre-Eclampsia
Why
  1. The study's listed conditions name Pre-Eclampsia, a narrower term within Hypertension, Pregnancy-Induced.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Josip Juraj Strossmayer University of Osijek · Observational

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
80
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Hypertensive Disorder of Pregnancy
  • Gestational Hypertension
  • Preeclampsia

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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
03

In context

Pre-Eclampsia Reclassified

916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.

This study's planned enrollment of 80 is below the median of 165 across 397 observational studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

Josip Juraj Strossmayer University of Osijek is the lead sponsor of 26 studies on the registry; 9 are open to participants now.

Compared within Pre-Eclampsia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension, Pregnancy-Induced. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Chronic hypertension diagnosed before pregnancy.
  • Multiple pregnancy.
  • Pre-existing diabetes mellitus.
  • Chronic kidney disease.
  • disease.
  • Known cardiovascular disease.
  • Active infection or inflammatory disease.
  • .
  • Inability or unwillingness to provide .
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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.

06

What researchers measure

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

  5. ICAM-1 concentration

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

    Time frame: Baseline

  6. Endocan concentration

    Plasma endocan concentration measured as a marker of endothelial dysfunction.

    Time frame: Baseline

  7. von Willebrand factor (vWF)

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

    Time frame: Baseline

  8. Matrix metalloproteinase-9 (MMP-9)

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

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07728656
Lead sponsor
Josip Juraj Strossmayer University of Osijek
Collaborators
Osijek University Hospital
Responsible party
Ines Drenjancevic (Full Proffesor Tenure, Head of Department of Physiology and Immunology, Faculty of Medicine Osijek, Josip Juraj Strossmayer University of Osijek) — Principal investigator
First posted
Jul 27, 2026
Start date
Apr 1, 2026
Primary completion
Apr 30, 2029 (estimated)
Completion
Sep 30, 2029 (estimated)
Last update
Jul 27, 2026

Study contacts

Martina Vulin, MD, PhD
Contact
martina.vulin@mefos.hr
+38531512302
Ana Stupin, MD, PhD
Contact
ana.stupin@mefos.hr
+38531512800
Ana Stupin, MD, PhD
study chair · Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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