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

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05647876
• Other study ID #: KISO STUDY
• Status: Recruiting
• Start date: December 16, 2022
• Est. completion date: August 2045

Study information

• Verified date: May 2023
• Source: University of Copenhagen
• Contact: Lasse Gliemann, PhD
• Phone: +4535321632
• Email: gliemann[@]nexs.ku.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2045
• Est. primary completion date: December 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Menopause
• Physical Activity
• Vascular Dilation

Locations

Country	Name	City	State
Denmark	Deparment of Nutrition, Exercise and Sports	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive vascular function	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	pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Primary	Non-invasive vascular function	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	pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary	Changes in skeletal muscle expression of protein	Changes in skeletal muscle expression of protein across the menopausal transition, and with different physical activity levels. (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause; Western blots will be used to determine endothelial nitric oxide synthase (eNOS), cyclo-oxygenase 1 and 2, prostacyclin synthase, endothelin receptor A and B, VEGF (vascular endothelial growth factor), Thrombospondin-1, Flk-1 (VEGF receptor). All protein content measures will be presented as arbitrary units.	pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary	Changes in skeletal muscle and blood sample expression of RNA	Changes in skeletal muscle and blood sample expression of RNA across the menopausal transition, and with different physical activity levels. (pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause.; RNA sequencing will be used to determine changes in RNA profile, with specific focus on microRNA.	pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause
Secondary	Blood pressure	Changes in blood pressure across the menopausal transition	pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause