Hypertension,EssentialNCT06316271
Endothelial Function in Prehypertension
An observational study of Hypertension,Essential, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension,Essential
- How many people
- 90 participants
- Where
- 1 siteCroatia
- Study dates
- 1 Apr 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension
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
- Medical subject headings
- Essential Hypertension, Hypertension, Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Systemic macrovascular function
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Measured: Day 1
Aortic stiffness
Measurement of pulse wave velocity (PWV) using impedance cardiography.
Measured: Day 1
Left ventricle global longitudinal strain
Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.
Measured: Day 1
Secondary outcomes (7)
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.
Measured: Day 1
Activity of renin-angiotensin system (RAS)
ELISA measurement of plasma renin activity (PRA).
Measured: Day 1
Endothelial progenitor cells (EPCs)
Detection of EPCs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Measured: Day 1
Endothelial extracellular vesicles (eEVs)
Detection of eEVs using a two laser flow cytometer (FacsCanto II, Becton Dickinson) and CBA kits (cytometry beads assays).
Measured: Day 1
Systemic peripheral vascular resistance
Systemic peripheral vascular resistance assessement using non-invasive impedance cardiography (ICG).
Measured: Day 1
Autonomic nervous system (ANS) activity
Assessment of a 5-minute heart rate variability (5-min HRV).
Measured: Day 1
Matrix metalloproteinase 9
ELISA measurement of serum matrix metalloproteinase 9 level.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Josip Juraj Strossmayer University of Osijek
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Center Osijek
- Responsible party
- Principal investigator, Ines Drenjancevic, Josip Juraj Strossmayer University of Osijek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316271
- Sponsor's protocol ID
- PreHT 2024
- Status last verified
- Mar 2024
- First submitted
- 2 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction and Cardiovascular Remodeling in Pathophyisiology of Prehypertension
- ClinicalTrials.gov ID
- NCT06316271
- Acronym / sponsor ID
- PreHT 2024
- Conditions
- Hypertension,Essential
- Keywords
- hypertension, prehypertension, endothelium, left ventricle, hemodynamics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Josip Juraj Strossmayer University of OsijekUniversity, hospital or other
- Collaborators
- University Hospital Center Osijek
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adults of both sexes with normotensive, prehypertensive and grade I hypertension blood pressure values
Key exclusion criteria (6 listed)
- cardiovascular diseases, but grade I hypertension (BP 140-150/90-100 mmHg)
- diabetes
- kidney disease
- cerebrovascular diseases
- peripheral artery disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systemic microvascular function
Time frame: Day 1
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)
Systemic macrovascular function
Time frame: Day 1
Vascular ultrasound measurement of brachial artery flow mediated dilation (FMD)
Aortic stiffness
Time frame: Day 1
Measurement of pulse wave velocity (PWV) using impedance cardiography.
Left ventricle global longitudinal strain
Time frame: Day 1
Global longitudinal strain (GLS) of left ventricle obtained by two-dimensional speckle tracking echocardiography.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension,Essential, run by Josip Juraj Strossmayer University of Osijek at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ines Drenjančević, MD, PhD (+38531512800, ines.drenjancevic@mefos.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systemic microvascular function (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.