Recruiting

Observational Study

Sponsor:

University of Minnesota

Code:

NCT04439370

Conditions

Hypertension

Menopause, Premature

Menopause

Blood Pressure

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

Interventions

Microneurography to measure muscle sympathetic nerve activity (MSNA)

Baroreflex sensitivity testing

Sympathoexcitatory Maneuvers

Blood tests

Study Details

Brief 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.

Conditions

Hypertension

Menopause, Premature

Menopause

Blood Pressure

Study ID

NCT04439370

Start date

Oct 1, 2019

Status verified date

Jan, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Interventions and Outcome Measures

Arms

Aim 1: Postmenopausal Women

Participants in this group are postmenopausal women.

Aim 1: Premenopausal Women

Participants in this group are premenopausal women.

Aim 2: Premature/Early Menopause

Participants in this group women who experienced premature or early menopause.

Aim 2: Typical-Age Menopause

Participants in this group are women who experienced menopause at a typical age.

Interventions

Microneurography to measure muscle sympathetic nerve activity (MSNA)

Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves

Baroreflex sensitivity testing

Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.

Sympathoexcitatory Maneuvers

Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed

Blood tests

Serum FSH, estrogen, progesterone, and testosterone will be measured

Primary outcome measure

  • Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute) [ Time Frame: 3 hours ]
  • Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats) [ Time Frame: 3 hours ]
  • Cardiac baroreflex sensitivity [ Time Frame: 3 hours ]
  • Sympathetic baroreflex sensitivity [ Time Frame: 3 hours ]
  • Systolic Blood Pressure (mmHg) [ Time Frame: 3 hours ]
  • Diastolic Blood Pressure (mmHg) [ Time Frame: 3 hours ]
  • Mean Arterial Blood Pressure (mmHg) [ Time Frame: 3 hours ]
  • Heart Rate (beats/min) [ Time Frame: 3 hours ]

Central Contacts and Locations

Central contacts

Manda Keller-Ross, PhD, DPT, PT

612-625-3175kell0529@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Manda Keller-Ross, PhD, DPT, PT

612-625-3175kell0529@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-01-08.