Understanding how menopause affects heart disease risk
A Longitudinal Study to Identify Mechanisms of Menopause on Cardiovascular Disease Risk
This study is trying to see how menopause affects heart disease risk in women by following them for at least 10 years and looking at changes in their heart and blood vessels.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 40 Years to 61 Years |
| Sex | Female |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05647876 on ClinicalTrials.gov |
What this trial studies
This observational study will follow a cohort of 200 women from before menopause through at least 10 years post-menopause to investigate how the cessation of estrogen impacts cardiovascular disease risk. The study will utilize advanced invasive methodologies to monitor changes in blood vessels, the heart, and the brain, while also analyzing microRNA sequencing from blood and tissue samples. By examining these factors, the researchers aim to uncover the mechanisms linking menopause to increased cardiovascular risks.
Who should consider this trial
Good fit: Ideal candidates are women with regular menstruation who are approaching menopause.
Not a fit: Patients with chronic diseases, those on hormone therapy, or individuals with significant cardiovascular risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for managing cardiovascular health in postmenopausal women.
How similar studies have performed: While there have been studies on menopause and cardiovascular health, this specific longitudinal approach focusing on microRNA and invasive methodologies is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen
- Deparment of Nutrition, Exercise and Sports — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Lasse Gliemann, PhD — Department of Nutrition, Exercise and Sports, University of Copenhagen, 2200 Copenhagen, Denmark
- Study coordinator: Lasse Gliemann, PhD
- Email: gliemann@nexs.ku.dk
- Phone: +4535321632
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.