Endothelial Function in Prehypertension

NCT06316271 | Not Yet Recruiting

• 1 other identifier: PreHT 2024
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential

Keywords

hypertension; prehypertension; endothelium; left ventricle; hemodynamics

Outcome Measures

Primary Outcomes (4)

• 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)

  Day 1

• Systemic macrovascular function

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

  Day 1

• Aortic stiffness

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

  Day 1

• Left ventricle global longitudinal strain

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

  Day 1

Secondary Outcomes (7)

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

  Day 1

• Activity of renin-angiotensin system (RAS)

  Day 1

• Endothelial progenitor cells (EPCs)

  Day 1

• Endothelial extracellular vesicles (eEVs)

  Day 1

• Systemic peripheral vascular resistance

  Day 1

Study Arms (3)

Normotensive Group

BP less than or equal to 129/84 mmHg

Prehypertensive Group

BP 130-139/85-89 mmHg

Hypertensive Group

BP 140-150/90-100 mmHg

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Faculty of Medicine Osijek

Osijek, 31000, Croatia

Location

Biospecimen

Retention: SAMPLES WITH DNA

serum, peripheral blood mononuclear cells (PBMCs)

MeSH Terms

Conditions

Essential Hypertension; Hypertension; Prehypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Ines Drenjančević, MD, PhD

CONTACT

+38531512800; ines.drenjancevic@mefos.hr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean for Science Faculty of Medicine Osijek

Study Record Dates

• First Submitted: March 2, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)