Endothelial Function in Prehypertension

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorJosip Juraj Strossmayer University of Osijek

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)

diabetes

kidney disease

cerebrovascular diseases

Trial population

Healthy subjects will be divided in the three study groups based on BP assessment using ambulatory blood pressure monitoring (ABPM). Hypertensive group will include only newly diagnosed patients who have not taken antihypertensive therapy.

Trial design

Design model

Case-crossover

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

90 Participants
are grouped into 3 trial groups
Group A: Normotensive Group
Group B: Prehypertensive Group
Group C: Hypertensive Group

Trial outcomes

Primary outcomes

1

Systemic microvascular function

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)

Time frame
Day 1
2

Systemic macrovascular function

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

Time frame
Day 1
3

Aortic stiffness

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

Time frame
Day 1
4

Left ventricle global longitudinal strain

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

Time frame
Day 1

Secondary outcomes

1

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

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.

Time frame
Day 1
2

Activity of renin-angiotensin system (RAS)

ELISA measurement of plasma renin activity (PRA).

Time frame
Day 1
3

Endothelial progenitor cells (EPCs)

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

Time frame
Day 1
4

Endothelial extracellular vesicles (eEVs)

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

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Josip Juraj Strossmayer University of Osijek

Lead sponsor

University Hospital Center Osijek

Collaborator

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