Endothelial Function in Prehypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hypertension,Essential. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Croatia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension
Overview
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.
Primary outcome measures
- Systemic microvascular function [Time frame: Day 1]
- Systemic macrovascular function [Time frame: Day 1]
- Aortic stiffness [Time frame: Day 1]
- Left ventricle global longitudinal strain [Time frame: Day 1]
Secondary outcome measures (7)
- Oxidative stress - 8-iso-prostaglandin F2α (8-iso-PGF2α) [Time frame: Day 1]
- Activity of renin-angiotensin system (RAS) [Time frame: Day 1]
- Endothelial progenitor cells (EPCs) [Time frame: Day 1]
- Endothelial extracellular vesicles (eEVs) [Time frame: Day 1]
- Systemic peripheral vascular resistance [Time frame: Day 1]
- Autonomic nervous system (ANS) activity [Time frame: Day 1]
- Matrix metalloproteinase 9 [Time frame: Day 1]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-crossover
Study locations
Croatia · 1 center
- Faculty of Medicine Osijek — Osijek
Identifiers
NCT: NCT06316271 · PreHT 2024