HypertensionHYPER-endoEV-aNCT07728630
Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Adults With Newly Diagnosed Hypertension
An observational study of Hypertension and Endothelial Function, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial summary
Hypertension is associated with endothelial dysfunction, an early event in the development of cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation and vascular injury; however, their relationship with blood pressure and microvascular… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Endothelial Function
- How many people
- 80 participants
- Where
- 1 siteCroatia
- Study dates
- 1 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of adult men and women aged 18 years and older recruited from the outpatient clinics of the University Hospital Centre Osijek, Croatia. The study will include normotensive individuals and patients with newly diagnosed, previously untreated primary hypertension. Healthy volunteers will serve as the control group.
Who may be able to join
- Adults aged 18 years or older.
- Ability and willingness to provide written informed consent.
- Normotensive individuals or individuals with newly diagnosed, previously untreated primary hypertension, classified according to the European Society of Hypertension (ESH) guidelines.
- Ability to comply with all study procedures.
Who cannot join
- Secondary hypertension.
- Previous treatment with antihypertensive medication.
- History of cardiovascular disease (except newly diagnosed primary hypertension in the hypertensive group).
- Diabetes mellitus.
- Chronic kidney disease.
- Cerebrovascular disease.
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- Peripheral arterial disease.
- Acute or chronic inflammatory or infectious disease.
- Active malignancy.
- Pregnancy or breastfeeding.
- Current use of oral contraceptives, hormone replacement therapy, or medications known to affect endothelial function.
- 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.
Ivana Jukić, MD, PhD contact
Croatia1 site, 1 recruiting
- Recruiting
Faculty of Medicine Osijek
Osijek, 31000
Ana Stupin, MD, PhD, +38531512800, ana.stupin@mefos.hr
Ivana Jukić, MD, PhD, +38531512800, ivana.jukic@mefos.hr
About this study
Official title: Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Adults With Newly Diagnosed Untreated Hypertension
Hypertension is associated with endothelial dysfunction, an early event in the development of cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation and vascular injury; however, their relationship with blood pressure and microvascular endothelial function in untreated hypertension remains insufficiently understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive adults and adults with newly diagnosed, untreated primary hypertension. In addition, the study will investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and established circulating biomarkers of endothelial activation. The findings may improve understanding of the role of EEVs in early hypertension and support their potential use as non-invasive biomarkers of endothelial dysfunction and cardiovascular risk.
- Conditions
- Hypertension, Endothelial Function
- Keywords
- Hypertension, Primary Hypertension, Endothelial Dysfunction, Endothelial Extracellular Vesicles, Extracellular Vesicles, Endothelial Activation, Biomarkers, Microvascular Function, Laser Doppler Flowmetry, Post-Occlusive Reactive Hyperemia, Vascular Function
- Medical subject headings
- Hypertension, 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 | Adults aged 18 years or older with normal office blood pressure according to the European Society of Hypertension (ESH) guidelines and without a history of hypertension or antihypertensive treatment. | |
| Adults With Newly Diagnosed Untreated Primary Hypertension | Adults aged 18 years or older with newly diagnosed, previously untreated primary hypertension according to the European Society of Hypertension (ESH) guidelines and no prior use of antihypertensive medication. |
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 (7)
PORH response (R-O%)
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
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 May 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 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
- Ana Stupin, MD, PhD, Study chair, Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728630
- Sponsor's protocol ID
- HYPER-endoEV-adults
- Acronym
- HYPER-endoEV-a
- Status last verified
- May 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 Adults With Newly Diagnosed Untreated Hypertension
- ClinicalTrials.gov ID
- NCT07728630
- Acronym / sponsor ID
- HYPER-endoEV-a / HYPER-endoEV-adults
- Conditions
- Hypertension, Endothelial Function
- Keywords
- Hypertension, Primary Hypertension, Endothelial Dysfunction, Endothelial Extracellular Vesicles, Extracellular Vesicles, 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 May 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.
Hypertension is associated with endothelial dysfunction, an early event in the development of cardiovascular disease. Endothelial extracellular vesicles (EEVs) have emerged as promising biomarkers of endothelial activation and vascular injury; however, their relationship with blood pressure and microvascular endothelial function in untreated hypertension remains insufficiently understood. This observational case-control study aims to compare circulating EEV concentrations between normotensive adults and adults with newly diagnosed, untreated primary hypertension. In addition, the study will investigate the associations between EEV levels, blood pressure, microvascular endothelial function assessed by laser Doppler flowmetry, and established circulating biomarkers of endothelial activation. The findings may improve understanding of the role of EEVs in early hypertension and support their potential use as non-invasive biomarkers of endothelial dysfunction and cardiovascular risk.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normotensive Controls | – | –Adults aged 18 years or older with normal office blood pressure according to the European Society of Hypertension (ESH) guidelines and without a history of hypertension or antihypertensive treatment. |
| Adults With Newly Diagnosed Untreated Primary Hypertension | – | –Adults aged 18 years or older with newly diagnosed, previously untreated primary hypertension according to the European Society of Hypertension (ESH) guidelines and no prior use of antihypertensive medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult men and women aged 18 years and older recruited from the outpatient clinics of the University Hospital Centre Osijek, Croatia. The study will include normotensive individuals and patients with newly diagnosed, previously untreated primary hypertension. Healthy volunteers will serve as the control group.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older.
- Ability and willingness to provide written informed consent.
- Normotensive individuals or individuals with newly diagnosed, previously untreated primary hypertension, classified according to the European Society of Hypertension (ESH) guidelines.
- Ability to comply with all study procedures.
Key exclusion criteria (12 listed)
- Secondary hypertension.
- Previous treatment with antihypertensive medication.
- History of cardiovascular disease (except newly diagnosed primary hypertension in the hypertensive group).
- 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.
7 secondary outcomes
PORH response (R-O%)
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
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 contact
Ana Stupin, 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 Hypertension and Endothelial Function, 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 12 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 Ana Stupin, MD, PhD (+38531512800, ana.stupin@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.