Endothelial Extracellular Vesicles as Biomarkers of Endothelial Activation in Adults With Newly Diagnosed Hypertension

NCT07728630 | Recruiting

• 1 other identifier: HYPER-endoEV-adults
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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 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

Endothelial Function; Hypertension

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

Outcome Measures

Primary Outcomes (1)

• Plasma endothelial extracellular vesicle concentration

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

  Baseline

Secondary Outcomes (7)

• PORH response (R-O%)

  Baseline

• Acetylcholine-induced vasodilation (AChID)

  Baseline

• Sodium nitroprusside-induced vasodilation (SNPID)

  Baseline

• VCAM-1 concentration

  Baseline

• ICAM-1 concentration

  Baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Josip Juraj Strossmayer University of Osijek: lead
• Osijek University Hospital: collaborator

Study Sites (1)

Faculty of Medicine Osijek

Osijek, 31000, Croatia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral venous blood samples will be collected from all participants. Plasma will be isolated and stored for subsequent analyses of endothelial extracellular vesicles and endothelial biomarkers.

MeSH Terms

Conditions

Hypertension; Essential Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Ana Stupin, MD, PhD

  Faculty of Medicine Osijek, Josip Juraj Strossmayer of Osijek

  STUDY CHAIR

Central Study Contacts

Ana Stupin, MD, PhD

CONTACT

+38531512800; ana.stupin@mefos.hr

Ivana Jukić, MD, PhD

CONTACT

ivana.jukic@mefos.hr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professore Tenure, Head of Department of Physiology and Immunology, Faculty of Medicine Osijek

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 27, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: July 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)