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NCT Number: NCT06316271

Endothelial Function in Prehypertension

In the frame of this proposal investigators will test the hypothesis that high normal blood pressure (prehypertension; PreHT) induces systemic endothelial dysfunction and endothelial activation in both micro- and macrocirculation, reduces re-endothelialization potential of human endothelial progenitor cells (EPCs) and increases the level of endothelial extracellular vesicles (EVs), which are accompanied by increased oxidative stress level. Furthermore, initial vascular and left ventricle (LV) remodeling contributes to changes in systemic hemodynamics and may be influenced by altered regulatory role of renin-angiotensin system (RAS) and autonomic nervous system (ANS) in PreHT but otherwise healthy individuals. To distinguish high normal blood pressure effect from those considered normal or high, study will be performed in three groups of individuals: prehypertensive (BP 130-139/85-89 mmHg), hypertensive (stage I, BP 140-150/90-100 mmHg), and controls (BP less than or equal to 129/85 mmHg). Altogether, the impairment of normal vascular relaxation mechanisms, endothelial activation as well as vascular and LV remodeling could play crucial role in increased cardiovascular risk and CVDs incidence in PreHT individuals. Moreover, the prognostic significance of assessing endotehlial dysfunction in hypertension (as well as in PreHT) is yet to be established.

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values

Exclusion criteria

  • cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)
  • diabetes
  • kidney disease
  • cerebrovascular diseases
  • peripheral artery disease
  • taking oral contraceptives or any drugs that could affect the endothelium

Treatment and study plan

Primary outcomes

  1. Systemic microvascular function

    Time frame: Day 1

    Skin microvascular reactivity assessed by Laser Doppler flowmetry (post-occlusive reactive hyperemia, iontophoresis of acetylcholine and sodium nitroprusside, local thermal hyperemia) - measured in perfusion units (PU)

  2. Systemic macrovascular function

    Time frame: Day 1

    Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)

  3. Aortic stiffness

    Time frame: Day 1

    Measurement of pulse wave velocity (PWV) using impedance cardiography.

  4. Left ventricle global longitudinal strain

    Time frame: Day 1

    Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.

Secondary outcomes

  1. Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α)

    Time frame: Day 1

    ELISA measurement of serum 8-iso-PGF2α concentration. 8-iso-PGF2α is an isoprostane that is produced by the non-enzymatic peroxidation of arachidonic acid in membrane phospholipids.

  2. Activity of renin-angiotensin system (RAS)

    Time frame: Day 1

    ELISA measurement of plasma renin activity (PRA).

  3. Endothelial progenitor cells (EPCs)

    Time frame: Day 1

    Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).

  4. Endothelial extracellular vesicles (eEVs)

    Time frame: Day 1

    Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).

  5. Systemic peripheral vascular resistance

    Time frame: Day 1

    Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).

  6. Autonomic nervous system (ANS) activity

    Time frame: Day 1

    Assessment of a 5-minute heart rate variability (5-min HRV).

  7. Matrix metalloproteinase 9

    Time frame: Day 1

    ELISA measurement of serum matrix metalloproteinase 9 level.

Study contacts

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

Ines Drenjančević, MD, PhD

CONTACT

[email protected]

+38531512800

Sponsors and collaborators

Lead sponsor

Josip Juraj Strossmayer University of Osijek

Other

Collaborators

  • University Hospital Center Osijek

Registry information

Official study title

Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Mar 18, 2024

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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