Pediatric HypertensionHYPER-endoEV-cNCT07728643
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Children With Newly Diagnosed Hypertension
An observational study of Pediatric Hypertension and Primary Hypertension, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Childhood hypertension is associated with early endothelial dysfunction and an increased risk of future cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their role in pediatric hypertension remains poorly understood. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Hypertension, Primary Hypertension, Endothelial Dysfunction
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2026to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population will include children and adolescents recruited from the outpatient clinics of the Department of Pediatrics, University Hospital Centre Osijek, Croatia. Participants will comprise normotensive children and adolescents and those with newly diagnosed, previously untreated primary hypertension, classified according to current pediatric hypertension guidelines.
Who may be able to join
- Children and adolescents aged 6-17 years.
- Written informed consent from a parent or legal guardian and assent from the participant when appropriate.
- Normotensive status or newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines.
- Ability to comply with study procedures.
Who cannot join
- Secondary hypertension.
- Previous antihypertensive treatment.
- Congenital heart disease or other significant cardiovascular disease.
- Diabetes mellitus.
- Chronic kidney disease.
- Autoimmune or chronic inflammatory disease.
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- Acute infection at the time of enrollment.
- Malignancy.
- Use of medications known to affect endothelial function.
- Inability to comply with study procedures.
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, 31000
Mia Damašek, MD, mdmiadamasek@gmail.com
About this study
Official title: Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension
Childhood hypertension is associated with early endothelial dysfunction and an increased risk of future cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their role in pediatric hypertension remains poorly understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive children and children with newly diagnosed, untreated primary hypertension. 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 in pediatric hypertension and support the development of non-invasive biomarkers for early cardiovascular risk assessment.
- Keywords
- Pediatric Hypertension, Childhood Hypertension, Primary Hypertension, Endothelial Extracellular Vesicles, Endothelial Dysfunction, Endothelial Activation, Biomarkers, Microvascular Function, Laser Doppler Flowmetry, Cardiovascular Risk
- Medical subject headings
- Essential Hypertension
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 Controls | Children and adolescents with normal blood pressure according to current pediatric hypertension guidelines. | |
| Newly Diagnosed Untreated Primary Hypertension | Children and adolescents with newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension 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 Pediatric HypertensionStudies 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
- Ivana Jukić, MD, PhD, Study chair, Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728643
- Sponsor's protocol ID
- HYPER-endoEV-children
- Acronym
- HYPER-endoEV-c
- Status last verified
- Jul 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Children With Newly Diagnosed Untreated Primary Hypertension
- ClinicalTrials.gov ID
- NCT07728643
- Acronym / sponsor ID
- HYPER-endoEV-c / HYPER-endoEV-children
- Keywords
- Pediatric Hypertension, Childhood Hypertension, Primary Hypertension, Endothelial Extracellular Vesicles, Endothelial Dysfunction, Endothelial Activation, Biomarkers, Microvascular Function
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- Osijek University Hospital
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood hypertension is associated with early endothelial dysfunction and an increased risk of future cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation; however, their role in pediatric hypertension remains poorly understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive children and children with newly diagnosed, untreated primary hypertension. 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 in pediatric hypertension and support the development of non-invasive biomarkers for early cardiovascular risk assessment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotensive Controls | – | –Children and adolescents with normal blood pressure according to current pediatric hypertension guidelines. |
| Newly Diagnosed Untreated Primary Hypertension | – | –Children and adolescents with newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population will include children and adolescents recruited from the outpatient clinics of the Department of Pediatrics, University Hospital Centre Osijek, Croatia. Participants will comprise normotensive children and adolescents and those with newly diagnosed, previously untreated primary hypertension, classified according to current pediatric hypertension guidelines.
Key inclusion criteria (4 listed)
- Children and adolescents aged 6-17 years.
- Written informed consent from a parent or legal guardian and assent from the participant when appropriate.
- Normotensive status or newly diagnosed, previously untreated primary hypertension according to current pediatric hypertension guidelines.
- Ability to comply with study procedures.
Key exclusion criteria (10 listed)
- Secondary hypertension.
- Previous antihypertensive treatment.
- Congenital heart disease or other significant cardiovascular disease.
- Diabetes mellitus.
- Chronic kidney disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma endothelial extracellular vesicle concentration
Time frame: Baseline
Concentration of circulating endothelial extracellular vesicles quantified by flow cytometry following size-exclusion chromatography isolation.
8 secondary outcomes
Post-occlusive reactive hyperemia (PORH)
Time frame: Baseline
Acetylcholine-induced vasodilation (AChID)
Time frame: Baseline
Sodium nitroprusside-induced vasodilation (SNPID)
Time frame: Baseline
VCAM-1 concentration
Time frame: Baseline
ICAM-1 concentration
Time frame: Baseline
Endocan concentration
Time frame: Baseline
von Willebrand factor (vWF)
Time frame: Baseline
Matrix metalloproteinase-9 (MMP-9)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ivana Jukić, MD, PhD study chair
Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Hypertension and Primary Hypertension, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ivana Jukić, MD, PhD (+38531512800, medicina@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma endothelial extracellular vesicle concentration (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.