Identifying Biomarkers for Endothelial Dysfunction in Women With Preeclampsia

NCT ID: NCT07084727

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2025-12-15

Brief 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. 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional group

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.

Group Type: OTHER

Arterial stiffness

Intervention Type: OTHER

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 dilatation

Intervention Type: OTHER

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 analyzer

Intervention Type: OTHER

Eye imaging measures the capacity with which your blood vessels in the retina can expand in response to a flicker light stimulation.

Interventions

Arterial stiffness

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.

Intervention Type: OTHER

Flow-meditad dilatation

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.

Intervention Type: OTHER

Dynamic retinal vessel analyzer

Eye imaging measures the capacity with which your blood vessels in the retina can expand in response to a flicker light stimulation.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• at least 18 years old
• willing to undergo vascular assessments
• informed consent signed

Exclusion Criteria

• Unwilling to provide informed consent
• Open-angle glaucoma
• Epilepsia
• (gestational) Diabetes
• Multiple pregnancies
• Fetal malformations
• Hypercholesterolemia
• Kidney disease
• Auto-immune disorders
• Connective tissue diseases

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Studies cardiologie

Role: CONTACT

studies.cardiologie@uza.be

+32 3 821 40 74

Facility Contacts

Studies cardiologie

Role: primary

studies.cardiologie@uza.be

+32 3 821 40 74

Other Identifiers

7765

Identifier Type: -

Identifier Source: org_study_id