Hypertensive Disorder of PregnancyHYPER-endoEV-pNCT07728656
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Pregnant Women With Hypertensive Disorders of Pregnancy
An observational study of Hypertensive Disorder of Pregnancy and Gestational Hypertension, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypertensive Disorder of Pregnancy, Gestational Hypertension, Preeclampsia
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2026to 30 Sep 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Chronic hypertension diagnosed before pregnancy.
- Multiple pregnancy.
- Pre-existing diabetes mellitus.
- Chronic kidney disease.
- Autoimmune disease.
- Known cardiovascular disease.
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- Active infection or inflammatory disease.
- Malignancy.
- Inability or unwillingness to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Osijek
Osijek
Ana Stupin, MD, PhD, +38531512800, medicina@mefos.hr
About this study
Official title: Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced 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.
- 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
- Medical subject headings
- Toxemia, Hypertension, Pregnancy-Induced, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma endothelial extracellular vesicle concentration
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
Measured: Baseline
Secondary outcomes (8)
Post-occlusive reactive hyperemia (PORH)
Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.
Measured: Baseline
Acetylcholine-induced vasodilation (AChID)
Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.
Measured: Baseline
Sodium nitroprusside-induced vasodilation (SNPID)
Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.
Measured: Baseline
VCAM-1 concentration
Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.
Measured: Baseline
ICAM-1 concentration
Plasma intercellular adhesion molecule-1 (ICAM-1) concentration measured as a marker of endothelial activation.
Measured: Baseline
Endocan concentration
Plasma endocan concentration measured as a marker of endothelial dysfunction.
Measured: Baseline
von Willebrand factor (vWF)
Plasma von Willebrand factor concentration measured as a marker of endothelial injury.
Measured: Baseline
Matrix metalloproteinase-9 (MMP-9)
Plasma MMP-9 concentration measured as a marker of vascular remodeling and endothelial dysfunction.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start1 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive Disorder of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- Osijek University Hospital
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
- Investigators
- Ana Stupin, MD, PhD, Study chair, Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728656
- Sponsor's protocol ID
- HYPER-endoEV-pregnancy
- Acronym
- HYPER-endoEV-p
- Status last verified
- Jun 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No