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NCT Number: NCT05277233

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.

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Key information

Conditions

Preeclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Myocardial perfusion

    Time frame: Day 2

    Measured by adenosine stress Magnetic Resonance Imaging (ml/min/g)

Secondary outcomes

  1. Cardiac fibrosis

    Time frame: Day 2

    Measured by Magnetic Resonance Imaging (g)

  2. Immune cell phenotypes

    Time frame: Day 1

    Measured in isolated peripheral blood mononuclear cells

  3. Concentration of N-terminal prohormone of brain natriuretic peptide

    Time frame: Day 1

    Measured in serum (ng/l)

  4. Concentration of brain natriuretic peptide

    Time frame: Day 1

    Measured in serum (ng/l)

  5. Urinary protein

    Time frame: Day 1

    Measured in spot urine (mg)

  6. Advanced glycation end products

    Time frame: Day 1

    Measured by skin autofluorescence (arbitrary units)

  7. Body fat mass

    Time frame: Day 1

    Measured by bioimpedance analysis (%)

  8. Body fat-free mass

    Time frame: Day 1

    Measured by bioimpedance analysis (%)

  9. Hand grip strength

    Time frame: Day 1

    Measured by dynamometer (kg)

  10. Systolic blood pressure

    Time frame: Day 1

    Mean of three consecutive blood pressure measurements (mmHg)

  11. Diastolic blood pressure

    Time frame: Day 1

    Mean of three consecutive blood pressure measurements (mmHg)

  12. Pulse wave velocity

    Time frame: Day 1

    Calculated by algorithm based on age and blood pressure values (m/s)

  13. Flow-mediated dilation

    Time frame: Day 1

    Measured by brachial artery diameter (µm)

  14. Reactive hyperemia index

    Time frame: Day 1

    Measured by finger plethysmography

  15. Choroidal thickness

    Time frame: Day 1

    Measured with Optical Coherence Tomography (µm)

  16. Macular volume

    Time frame: Day 1

    Measured with Optical Coherence Tomography (mm³)

  17. Arterial dilation induced by retinal flicker stimulation

    Time frame: Day 1

    Measured with Dynamic Vessel Analyser (seconds)

  18. Venous dilation induced by retinal flicker stimulation

    Time frame: Day 1

    Measured with Dynamic Vessel Analyser (seconds)

Study contacts

Contact information is provided by the study sponsor or research team.

Kristin Kräker, PhD

CONTACT

[email protected]

+49 30 450540 328

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 14, 2022
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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