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NCT Number: NCT07728630

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

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Key information

Conditions

Hypertension Cardiovascular Diseases Endothelial Function Essential Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Location status: Recruiting

Location contact

Ana Stupin, MD, PhD

CONTACT

[email protected]

+38531512800

Ivana Jukić, MD, PhD

CONTACT

[email protected]

+38531512800

Ivana Tolj, MD, PhD

PRINCIPAL_INVESTIGATOR

Marko Stupin, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Plasma endothelial extracellular vesicle concentration

    Time frame: Baseline

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

Secondary outcomes

  1. PORH response (R-O%)

    Time frame: Baseline

    Microvascular endothelium-dependent vasodilation assessed by laser Doppler flowmetry following 1-minute arterial occlusion.

  2. Acetylcholine-induced vasodilation (AChID)

    Time frame: Baseline

    Endothelium-dependent microvascular vasodilation assessed by acetylcholine iontophoresis and laser Doppler flowmetry.

  3. Sodium nitroprusside-induced vasodilation (SNPID)

    Time frame: Baseline

    Endothelium-independent microvascular vasodilation assessed by sodium nitroprusside iontophoresis and laser Doppler flowmetry.

  4. VCAM-1 concentration

    Time frame: Baseline

    Plasma vascular cell adhesion molecule-1 (VCAM-1) concentration measured as a marker of endothelial activation.

  5. ICAM-1 concentration

    Time frame: Baseline

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

  6. Endocan concentration

    Time frame: Baseline

    Plasma endocan concentration measured as a marker of endothelial dysfunction.

  7. Matrix metalloproteinase-9 (MMP-9)

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Stupin, MD, PhD

CONTACT

[email protected]

+38531512800

Ivana Jukić, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • Osijek University Hospital

Registry information

Official study title

Endothelial Extracellular Vesicles as Biomarkers of Blood Pressure-Induced Endothelial Activation in Adults With Newly Diagnosed Untreated Hypertension

Acronym: HYPER-endoEV-a

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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