Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women (NCT04439370) | Clinical Trial Compass
RecruitingNot Applicable
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
United States160 participantsStarted 2019-10-01
Plain-language summary
This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Specifically, aim one will determine mechanisms driving autonomic dysregulation of BP in premature and early menopausal women and aim two will determine mechanisms driving autonomic dysregulation of BP in older menopausal women. The study design outlined below will permit testing of aim one and aim two.
Who can participate
Age range
35 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged 35-49 or 50-70 years of age who experienced premature (\<40) or early (≤45) menopause
* Premenopausal 35-49 years of age
* Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
* Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of \>30 mIU/mL
Exclusion Criteria:
* Current nicotine/tobacco use within the past six months
* Are diabetic or asthmatic
* Have diagnosed significant carotid stenosis
* Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
* Have existing metabolic or endocrine abnormities
* Take any heart/blood pressure medications that are determined to interfere with study outcomes
* IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
* Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
* Are pregnant or breastfeeding
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute)