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Recruiting NCT05647876

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

— Observational Menopause Cardiovascular Diseases Vascular Dilation Physical Activity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Menopause, Cardiovascular Diseases, Vascular Dilation, Physical Activity. Basic parameters: 40 years — 61 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Invasive vascular function [Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]
  • Non-invasive vascular function [Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]
Secondary outcome measures (3)
  • Changes in skeletal muscle expression of protein [Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]
  • Changes in skeletal muscle and blood sample expression of RNA [Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]
  • Blood pressure [Time frame: pre, 1yr. 3yr. , 5 yr., 10 yr. and 20 yr. post menopause]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Denmark · 1 center
  • Deparment of Nutrition, Exercise and Sports — Copenhagen

Identifiers

NCT: NCT05647876 · KISO STUDY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗