Cardiovascular Risk After Preeclampsia

Preeclampsia Clinical Trial

Official title:

Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05277233
• Other study ID #: CARPE
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: April 2026

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Kristin Kräker, PhD
• Phone: +49 30 450540 328
• Email: kristin.kraeker[@]charite.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Locations

Country	Name	City	State
Germany	Experimental and Clinical Research Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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