Cardiovascular Risk After Preeclampsia

Recruiting

• Conditions: Preeclampsia

• Registration Number: NCT05277233
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

Investigation of cardiovascular risk 5-15 years after early or late-onset preeclampsia by adenosine stress Magnetic Resonance Imaging and non-invasive methods like retinal vessel analysis, skin measurement of advanced glycation end products, flow-mediated dilation or pulse wave analysis in comparison to women after healthy pregnancies.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-18
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-14
• Study Start: 2022-04-04
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women
• 18-60 years
• 5-15 years postpartum

Exclusion Criteria

• Atrioventricular block, chronic obstructive pulmonary disease, bronchial asthma
• Pregnancy and/or active breastfeeding
• Glaucoma disease, epilepsy
• In addition for MRI: metal implants, electric devices, intolerance of contrast media, claustrophobia, renal or hepatic dysfunction (GFR < 30 ml/min)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Myocardial perfusion	Day 2	Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)

Secondary Outcome Measures

Name	Time	Method
Immune cell phenotypes	Day 1	Measured in isolated peripheral blood mononuclear cells
Body fat mass	Day 1	Measured by bioimpedance analysis (%)
Body fat-free mass	Day 1	Measured by bioimpedance analysis (%)
Choroidal thickness	Day 1	Measured with Optical Coherence Tomography (µm)
Arterial dilation induced by retinal flicker stimulation	Day 1	Measured with Dynamic Vessel Analyser (seconds)
Reactive hyperemia index	Day 1	Measured by finger plethysmography
Systolic blood pressure	Day 1	Mean of three consecutive blood pressure measurements (mmHg)
Concentration of brain natriuretic peptide	Day 1	Measured in serum (ng/l)
Urinary protein	Day 1	Measured in spot urine (mg)
Concentration of N-terminal prohormone of brain natriuretic peptide	Day 1	Measured in serum (ng/l)
Advanced glycation end products	Day 1	Measured by skin autofluorescence (arbitrary units)
Pulse wave velocity	Day 1	Calculated by algorithm based on age and blood pressure values (m/s)
Cardiac fibrosis	Day 2	Measured by Magnetic Resonance Imaging (g)
Hand grip strength	Day 1	Measured by dynamometer (kg)
Diastolic blood pressure	Day 1	Mean of three consecutive blood pressure measurements (mmHg)
Flow-mediated dilation	Day 1	Measured by brachial artery diameter (µm)
Macular volume	Day 1	Measured with Optical Coherence Tomography (mm³)
Venous dilation induced by retinal flicker stimulation	Day 1	Measured with Dynamic Vessel Analyser (seconds)

Trial Locations

Locations (1)

Experimental and Clinical Research Center; 🇩🇪 Berlin, Germany