Skip to content

Endothelial Function in Prehypertension

Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06316271
Enrollment
90
Registered
2024-03-18
Start date
2024-04-01
Completion date
2026-12-31
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension,Essential

Keywords

hypertension, prehypertension, endothelium, left ventricle, hemodynamics

Brief summary

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.

Interventions

None listed

Sponsors

University Hospital Center Osijek
CollaboratorUNKNOWN
Josip Juraj Strossmayer University of Osijek
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Systemic microvascular functionDay 1Skin 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)
Systemic macrovascular functionDay 1Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Aortic stiffnessDay 1Measurement of pulse wave velocity (PWV) using impedance cardiography.
Left ventricle global longitudinal strainDay 1Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.

Secondary

MeasureTime frameDescription
Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α)Day 1ELISA 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.
Activity of renin-angiotensin system (RAS)Day 1ELISA measurement of plasma renin activity (PRA).
Endothelial progenitor cells (EPCs)Day 1Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Endothelial extracellular vesicles (eEVs)Day 1Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Systemic peripheral vascular resistanceDay 1Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).
Autonomic nervous system (ANS) activityDay 1Assessment of a 5-minute heart rate variability (5-min HRV).
Matrix metalloproteinase 9Day 1ELISA measurement of serum matrix metalloproteinase 9 level.

Countries

Croatia

Contacts

Primary ContactInes Drenjančević, MD, PhD
ines.drenjancevic@mefos.hr+38531512800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026