Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women

This observational study is looking at how menopause, especially premature (before age 40) or early (before age 45) menopause, affects blood pressure regulation. Researchers will compare women who experienced early menopause to those who went through menopause at a typical age, as well as to women who are still premenopausal. They will use tests like microneurography (to measure nerve activity), baroreflex sensitivity testing, and other maneuvers to see how your body controls blood pressure. Blood tests will also measure hormones like FSH, estrogen, progesterone, and testosterone. The goal is to understand why some women might have blood pressure problems after early menopause. The study aims to enroll 160 women between 35 and 70 years old. Success will be measured by changes in muscle sympathetic nerve activity and cardiac baroreflex sensitivity after 3 hours.

Study design: This is an observational study aiming to enroll 160 women. It compares different groups of women based on their menopausal status and age.
What's involved: You would undergo diagnostic tests including microneurography, baroreflex sensitivity testing, sympathoexcitatory maneuvers, and blood tests.
Compensation: Not stated in the trial record.
Follow-up: Primary endpoints are measured at 3 hours.

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Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women

Recruiting

Not specifiedAges 35–70Observational

University of Minnesota

~160 participants

Updated 2026-01-08 on ClinicalTrials.gov

What's tested:Microneurography to measure muscle sympathetic nerve activity (MSNA)Baroreflex sensitivity testingSympathoexcitatory ManeuversBlood tests

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute)

Measured over 3 hours

+7 more outcomes measured

Conditions

Hypertension

Menopause, Premature

Menopause

Blood Pressure

Where it's being run

1 sites across 1 states

Minnesota1

Who to contact

Manda Keller-Ross, PhD, DPT, PT

[email protected]

612-625-3175

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Eligibility criteria

Inclusion

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

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

What this trial measures

Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute)3 hours
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per minute.
Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats)3 hours
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per 100 heart beats.
Cardiac baroreflex sensitivity3 hours
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units as ms/mmHg.
Sympathetic baroreflex sensitivity3 hours
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units of MSNA bursts/mmHg.
Systolic Blood Pressure (mmHg)3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Diastolic Blood Pressure (mmHg)3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Mean Arterial Blood Pressure (mmHg)3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Heart Rate (beats/min)3 hours
Heart rate will be measured with a three-lead electrocardiogram (ECG) and reported in units of beats/min.

Trialytics