Endothelial Function (FMD)DAISYNCT07084727
Identifying Biomarkers for Endothelial Dysfunction in Women With Preeclampsia
A study testing Arterial stiffness, Flow-meditad dilatation and Dynamic retinal vessel analyzer in people with Endothelial Function (FMD) and Preeclampsia, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Every pregnancy has a major impact on a woman's heart and blood vessels due to changes required by the body to maintain proper blood flow between mother and foetus. When the placenta does not work properly, preeclampsia can occur. An important first symptom is high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function (FMD), Preeclampsia, Retinal Vessels
- What is being tested?
- Arterial stiffness, Flow-meditad dilatation and Dynamic retinal vessel analyzer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2025to 15 Dec 2025
- Phase
- Interventional
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- at least 18 years old
- willing to undergo vascular assessments
- informed consent signed
Who cannot join
- Unwilling to provide informed consent
- Open-angle glaucoma
- Epilepsia
- (gestational) Diabetes
- Multiple pregnancies
- Fetal malformations
Show all 10Show fewer
- Hypercholesterolemia
- Kidney disease
- Auto-immune disorders
- Connective tissue diseases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Antwerp University Hospital
Edegem, Antwerp, 2650
Studies cardiologie, +32 3 821 40 74, studies.cardiologie@uza.be
About this study
Official title: Retinal Biomarkers as a Tool for Early Detection of Endothelial Dysfunction in Women With Preeclampsia
Every pregnancy has a major impact on a woman's heart and blood vessels due to changes required by the body to maintain proper blood flow between mother and foetus. When the placenta does not work properly, preeclampsia can occur. An important first symptom is high blood pressure. Women who have experienced preeclampsia are at higher risk of developing blood pressure and heart problems later on. Therefore, it is very important to detect changes in the blood vessel system so that they can be treated promptly and correctly. We aim to do this by using a new, non-invasive eye test that examines the blood vessels of the retina.
- Conditions
- Endothelial Function (FMD), Preeclampsia, Retinal Vessels
- Being tested
- Arterial stiffness, Flow-meditad dilatation, Dynamic retinal vessel analyzer
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial stiffnessOther
Non-invasive test. A blood pressure cuff and tonometer (a type of pen placed on the neck) are used to measure the speed at which a pressure wave propagates from one place to another.
Every time the heart contracts, a pressure wave is generated that propagates from the heart to the blood vessels at a certain speed. The stiffer the blood vessels, the faster the wave propagates.
Flow-meditad dilatationOther
This study measures the capacity with which blood vessels expand when we briefly cut off blood flow. The endothelium, the inner layer of blood vessels, regulates this expansion. By ultrasound, we measure the difference in diameter of the elbow artery. To cut off the blood flow, we clamp the forearm with a blood pressure cuff for 5 minutes.
When the blood pressure cuff is released, it triggers increased blood flow in the arm, causing the blood vessels to expand. We record this expansion using the above techniques.
Dynamic retinal vessel analyzerOther
Eye imaging measures the capacity with which your blood vessels in the retina can expand in response to a flicker light stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Other | All patients in this study will undergo all vascular assessments including pulse wave velocity, pulse wave analysis, flow-mediated dilation, fundus photography and dynamic retinal vessel analysis. Receives: Other: Arterial stiffness; Other: Flow-meditad dilatation; Other: Dynamic retinal vessel analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal biomarkers
Early (retinal) biomarkers for cardiovascular risk in patients with preeclampsia, assessed by DVA.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jul 2025
- Primary completion15 Nov 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial Function (FMD)Studies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084727
- Sponsor's protocol ID
- 7765
- Acronym
- DAISY
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Biomarkers as a Tool for Early Detection of Endothelial Dysfunction in Women With Preeclampsia
- ClinicalTrials.gov ID
- NCT07084727
- Acronym / sponsor ID
- DAISY / 7765
- Conditions
- Endothelial Function (FMD), Preeclampsia, Retinal Vessels
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 15 Nov 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 24 Jul 2025 (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.
Every pregnancy has a major impact on a woman's heart and blood vessels due to changes required by the body to maintain proper blood flow between mother and foetus. When the placenta does not work properly, preeclampsia can occur. An important first symptom is high blood pressure. Women who have experienced preeclampsia are at higher risk of developing blood pressure and heart problems later on. Therefore, it is very important to detect changes in the blood vessel system so that they can be treated promptly and correctly. We aim to do this by using a new, non-invasive eye test that examines the blood vessels of the retina.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Other | Other: Arterial stiffness, Other: Flow-meditad dilatation, Other: Dynamic retinal vessel analyzerAll patients in this study will undergo all vascular assessments including pulse wave velocity, pulse wave analysis, flow-mediated dilation, fundus photography and dynamic retinal vessel analysis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- at least 18 years old
- willing to undergo vascular assessments
- informed consent signed
Key exclusion criteria (10 listed)
- Unwilling to provide informed consent
- Open-angle glaucoma
- Epilepsia
- (gestational) Diabetes
- Multiple pregnancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial stiffnessNon-invasive test. A blood pressure cuff and tonometer (a type of pen placed on the neck) are used to measure the speed at which a pressure wave propagates from one place to another. Every time the heart contracts, a pressure wave is generated that propagates from the heart to the blood vessels at a certain speed. The stiffer the blood vessels, the faster the wave propagates. | Other | Interventional group |
| Flow-meditad dilatationThis study measures the capacity with which blood vessels expand when we briefly cut off blood flow. The endothelium, the inner layer of blood vessels, regulates this expansion. By ultrasound, we measure the difference in diameter of the elbow artery. To cut off the blood flow, we clamp the forearm with a blood pressure cuff for 5 minutes. When the blood pressure cuff is released, it triggers increased blood flow in the arm, causing the blood vessels to expand. We record this expansion using the above techniques. | Other | Interventional group |
| Dynamic retinal vessel analyzerEye imaging measures the capacity with which your blood vessels in the retina can expand in response to a flicker light stimulation. | Other | Interventional group |
Primary outcome
Retinal biomarkers
Time frame: Baseline
Early (retinal) biomarkers for cardiovascular risk in patients with preeclampsia, assessed by DVA.
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 24 Jul 2025.
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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?
A study testing Arterial stiffness, Flow-meditad dilatation and Dynamic retinal vessel analyzer in people with Endothelial Function (FMD) and Preeclampsia, run by University Hospital, Antwerp at 1 site in Belgium.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 24 Jul 2025. 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 Belgium. 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 Studies cardiologie (+32 3 821 40 74, studies.cardiologie@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal biomarkers (time frame: Baseline). 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 24 Jul 2025.