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Recruiting Observational

A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk

NCT05647876 · tracked via the Priya Life Science Denmark tracker
Phase
Observational
Started
2022-12-16
Last updated
2023-05-10

Condition(s) studied

MenopauseCardiovascular DiseasesVascular DilationPhysical Activity

Study summary

With the cessation of estrogen production at menopause, the risk of cardiovascular disease like arthrosclerosis, myocardial infarction and stroke increases dramatically. Physical activity is the single most powerful "drug" for maintaining and improving cardiovascular health, but recent data suggest that the positive effect of physical activity is lost at menopause. In this project the investigators will follow a cohort of 200 women from before the women enter menopause and until at least 10 years past menopause. By advanced invasive methodologies the investigators will monitor the changes that occur in the blood vessels of the circulation, the heart and the brain and combine this with microRNA sequencing of blood and tissue samples.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
61 Years
Healthy volunteers
Accepted
Inclusion Criteria: * Normal ECG * Regular menstruation Exclusion Criteria: * Participation in other clinical projects * Smokes or has smoked within the last 10 years * On hormone therapy * Has chronic diseases that are not expected, cf. the groups sought. Including heart problems, atrial fibrillation, cancer, immune diseases and previous strokes with functionally significant sequelae * Being treated with oral steroids * Has alcohol / drug abuse or is being treated with disulfiram (Antabus) * Is unable to understand the contents of the document with informed consent or the experimental procedures * Pregnancy or breastfeeding * Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg * ovariectomy * BMI\>28

Primary outcome measure(s)

  • Invasive vascular function — pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
    Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by intra-arterial infusions of acetylcholine and epoprostenol) in the brachial artery using ultrasound doppler
  • Non-invasive vascular function — pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
    Changes in vascular function across the menopausal transition (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause Vascular function is assessed by flow-mediated dilation (FMD) in the brachial artery using ultrasound doppler

Trial sites (1)

FacilityCityRegionStatus
Deparment of Nutrition, Exercise and Sports Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05647876 on ClinicalTrials.gov ↗ ← All trials in Denmark