Endothelial Function in Prehypertension

NCT ID: NCT06316271

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension,Essential

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Normotensive Group

BP less than or equal to 129/84 mmHg

No interventions assigned to this group

Prehypertensive Group

BP 130-139/85-89 mmHg

No interventions assigned to this group

Hypertensive Group

BP 140-150/90-100 mmHg

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital Center Osijek

UNKNOWN

Sponsor Role collaborator

Josip Juraj Strossmayer University of Osijek

OTHER

Sponsor Role lead

Responsible Party

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Ines Drenjancevic

Vice Dean for Science Faculty of Medicine Osijek

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Medicine Osijek

Osijek, , Croatia

Site Status

Countries

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Croatia

Central Contacts

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Ines Drenjančević, MD, PhD

Role: CONTACT

+38531512800

Other Identifiers

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PreHT 2024

Identifier Type: -

Identifier Source: org_study_id

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