Cardiovascular Risk After Preeclampsia

Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia

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.

Study Overview

• Status: Recruiting
• Conditions: Preeclampsia

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Kristin Kräker, PhD; Phone Number: +49 30 450540 328; Email: kristin.kraeker@charite.de

Study Locations

• Germany
  • Berlin, Germany, 13125
    • Recruiting
    • Experimental and Clinical Research Center
    • Contact: Kristin Kräker, PhD; Phone Number: +49 30 450540 328; Email: kristin.kraeker@charite.de
    • Contact: Anja Mähler, PhD; Phone Number: +49 30 450540 323; Email: anja.maehler@charite.de
    • Sub-Investigator: Jeanette Schulz-Menger, MD
    • Sub-Investigator: Ralf Dechend, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Woman 5-15 years after pregnancy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Early-onset preeclampsia; Defined as preeclampsia that develops before 34 weeks of gestation
Late-onset preeclampsia; Defined as preeclampsia that develops after 34 weeks of gestation
Control; Healthy pregnancies, matched to early and late-onset cases

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial perfusion	Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)	Day 2

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pre-Eclampsia
• Other Study ID Numbers: CARPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No