Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05985447

Menopause Related Influences on Leukocyte Distribution, Monocyte Function and Platelet Reactivity

Women and men show marked differences in cardiovascular risk profile and outcome. Women experience fewer cardiovascular events than men before menopause, but this relationship seems to reverse at menopause. These disparities are probably due to hormonal factors, especially the female sex hormone estrogen seems to have a protective influence on the development of atherosclerotic plaques premenopausal.

The underlying mechanisms of the effect of estrogens on the vessel wall are still insufficiently investigated. In this study, menopause related effects on leukocyte distribution and function as well on platelets and their aggregational response will be evaluated.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, 40225, Germany

Location status: Recruiting

Location contact

Clinical Trial Unit

CONTACT

[email protected]

+4921181105315

Lisa Dannenberg, MD

CONTACT

[email protected]

+492118105315

Lisa Dannenberg, MD

PRINCIPAL_INVESTIGATOR

About this study

Sex-specific differences in the risk profile and outcome of cardiovascular diseases are evident, which are probably due to hormonal factors. Women suffer significantly fewer cardiovascular events than men before menopause, after menopause this relationship seems to reverse. Moreover, outcome is worse in female patients compared to men.

Platelets and leukocytes play an essential role in cardiovascular risk. Nevertheless, the underlying mechanisms of the mechanistic effects of the hormone transition in menopause on leukocytes and platelets have only been insufficiently investigated so far. Moreover, effects of a possible hormone replacement therapy are insufficiently understood with contradictive literature concerning cardiovascular effects.

The aim in this study, is to analyse leukocyte and platelet function in dependence from menopause related changes in hormone levels of estrogen, testosterone, progesterone, LH and FSH. Moreover, hormone replacement therapy will be investigated.

For this purpose, blood samples from male and female patients will be investigated with regard to age and menopause status. The blood samples are analysed by FACS to differentiate the leukocytes and test for inflammatory properties and reactive oxygen species. The monocyte distribution divided according to the surface markers CD14 and CD16 is analysed. In addition, plasma from the patient samples will be used to assess hormone levels in the blood. In addition, patient data such as general laboratory parameters, risk and lifestyle factors are collected and associated with the hormone and lipid levels.

For platelet function analysis, light-transmittance aggregometry, flow cytometry (platelet leukocyte crosstalk, investigation of platelet surface markers for platelet activation and cell-cell-adhesion) will be investigated. Platelets secretory potency will be analysed by ATP-release. Moreover, platelet adhesion will be investigated by collagen-coated flow chambers. Platelet proteomics and RNA sequencing will complement the data in an unbiased approach. In addition in-vitro incubation analyses with estrogen and testosterone will be conducted to investigate hormone replacement therapy effects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 years
  • Male, female, diverse patients with current treatment in the Department of Cardiology, Pneumology and Angiology.
  • Persons who are able to understand and follow the instructions of the study staff
  • Written informed consent

Exclusion criteria

  • Age < 18 years
  • Lack of written consent to participate in the study
  • coagulation disorders

Treatment and study plan

Primary outcomes

  1. Leukocyte distribution measured by flow cytometry

    Time frame: single time, up to one day after inclusion

    CD45 (Leukocytes), CD3 (T-cells), CD14 (Monocytes), CD16 (Granulocytes), CD19 (B-cells)

  2. Platelet function

    Time frame: single time, up to one day after inclusion

    measured by light transmittance aggregometry (Parameters: Maximum of Aggregation, Slope

  3. Platelet surface markers, platelet leukocyte crosstalk (CD40, CD40L)

    Time frame: single time, up to one day after inclusion

    measured by flow cytometry (FACS)

Secondary outcomes

  1. Reactive Oxygen Species (ROS) Generation via CellRoxGreen [geometric mean]

    Time frame: single time, up to one day after inclusion

    measured by Flow Cytometry (FACS)

  2. Hormone levels of estrogen

    Time frame: single time, up to one day after inclusion

    measured by ELISA [ng/l]

  3. Hormone levels of testosterone measured by ELISA

    Time frame: single time, up to one day after inclusion

    measured by ELISA [ng/l]

  4. Hormone levels of progesterone

    Time frame: single time, up to one day after inclusion

    measured by ELISA [µg/l]

  5. Hormone levels of follicle stimulating hormone

    Time frame: single time, up to one day after inclusion

    measured by ELISA [µg/l]

  6. Hormone levels of luteinizing hormone

    Time frame: single time, up to one day after inclusion

    measured by ELISA [µg/l]

  7. Questionnaire including lifestyle factors, cardiovascular risk factors

    Time frame: single time, up to one day after inclusion

Study contacts

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

Lisa Dannenberg, MD

CONTACT

[email protected]

+492118105315

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

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.

Published trials that share one or more normalized conditions with this study.