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Cardiovascular Risk After Preeclampsia

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Recruiting
CT.gov ID
NCT05277233
Collaborator
(none)
60
Enrollment
1
Location
28.9
Anticipated Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Other
    Official Title:
    Endothelial Dysfunction and Cardiovascular Risk After Preeclampsia
    Actual Study Start Date :
    Apr 4, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Sep 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Myocardial perfusion [Day 2]

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

    Secondary Outcome Measures

    1. Cardiac fibrosis [Day 2]

      Measured by Magnetic Resonance Imaging (g)

    2. Immune cell phenotypes [Day 1]

      Measured in isolated peripheral blood mononuclear cells

    3. Concentration of N-terminal prohormone of brain natriuretic peptide [Day 1]

      Measured in serum (ng/l)

    4. Concentration of brain natriuretic peptide [Day 1]

      Measured in serum (ng/l)

    5. Urinary protein [Day 1]

      Measured in spot urine (mg)

    6. Advanced glycation end products [Day 1]

      Measured by skin autofluorescence (arbitrary units)

    7. Body fat mass [Day 1]

      Measured by bioimpedance analysis (%)

    8. Body fat-free mass [Day 1]

      Measured by bioimpedance analysis (%)

    9. Hand grip strength [Day 1]

      Measured by dynamometer (kg)

    10. Systolic blood pressure [Day 1]

      Mean of three consecutive blood pressure measurements (mmHg)

    11. Diastolic blood pressure [Day 1]

      Mean of three consecutive blood pressure measurements (mmHg)

    12. Pulse wave velocity [Day 1]

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

    13. Flow-mediated dilation [Day 1]

      Measured by brachial artery diameter (µm)

    14. Reactive hyperemia index [Day 1]

      Measured by finger plethysmography

    15. Choroidal thickness [Day 1]

      Measured with Optical Coherence Tomography (µm)

    16. Macular volume [Day 1]

      Measured with Optical Coherence Tomography (mm³)

    17. Arterial dilation induced by retinal flicker stimulation [Day 1]

      Measured with Dynamic Vessel Analyser (seconds)

    18. Venous dilation induced by retinal flicker stimulation [Day 1]

      Measured with Dynamic Vessel Analyser (seconds)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Experimental and Clinical Research Center Berlin Germany 13125

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Anja Maehler, Principal Investigator, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT05277233
    Other Study ID Numbers:
    • CARPE
    First Posted:
    Mar 14, 2022
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pre-Eclampsia

    Study Results

    No Results Posted as of Apr 20, 2022