Identifying Biomarkers for Endothelial Dysfunction in Women With Preeclampsia

NCT07084727 | Recruiting

• 1 other identifier: 7765
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Retinal biomarkers

  Early (retinal) biomarkers for cardiovascular risk in patients with preeclampsia, assessed by DVA.

  Baseline

Study Arms (1)

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.

Other: Arterial stiffness; Other: Flow-meditad dilatation; Other: Dynamic retinal vessel analyzer

Interventions

Arterial stiffness 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.

Interventional group

Flow-meditad dilatation 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.

Interventional group

Dynamic retinal vessel analyzer OTHER

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

Interventional group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Vascular Stiffness

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Studies cardiologie

CONTACT

+32 3 821 40 74; studies.cardiologie@uza.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2025
• Primary Completion: November 15, 2025
• Study Completion: December 15, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Locations

BE (1)