NCT04439370

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Oct 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Oct 2019Dec 2026

Study Start

First participant enrolled

October 1, 2019

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2019

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 19, 2020

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

7.3 years

First QC Date

October 28, 2019

Last Update Submit

January 5, 2026

Conditions

HypertensionMenopause, PrematureMenopauseBlood Pressure

Outcome Measures

Primary Outcomes (8)

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

    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.

    3 hours

  • Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats)

    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.

    3 hours

  • Cardiac baroreflex sensitivity

    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.

    3 hours

  • Sympathetic baroreflex sensitivity

    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.

    3 hours

  • Systolic Blood Pressure (mmHg)

    Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.

    3 hours

  • Diastolic Blood Pressure (mmHg)

    Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.

    3 hours

  • Mean Arterial Blood Pressure (mmHg)

    Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.

    3 hours

  • Heart Rate (beats/min)

    Heart rate will be measured with a three-lead electrocardiogram (ECG) and reported in units of beats/min.

    3 hours

Secondary Outcomes (12)

  • Respiratory Rate (breaths/min)

    3 hours

  • Heart Rate Variability (frequency)

    3 hours

  • Heart Rate Variability (time)

    3 hours

  • Borg Rating of Perceived Exertion

    3 hours

  • Numerical Pain Scale Rating

    3 hours

  • +7 more secondary outcomes

Study Arms (4)

Aim 1: Postmenopausal Women

Participants in this group are postmenopausal women.

Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic Test: Baroreflex sensitivity testingDiagnostic Test: Sympathoexcitatory ManeuversDiagnostic Test: Blood tests

Aim 1: Premenopausal Women

Participants in this group are premenopausal women.

Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic Test: Baroreflex sensitivity testingDiagnostic Test: Sympathoexcitatory ManeuversDiagnostic Test: Blood tests

Aim 2: Premature/Early Menopause

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

Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic Test: Baroreflex sensitivity testingDiagnostic Test: Sympathoexcitatory ManeuversDiagnostic Test: Blood tests

Aim 2: Typical-Age Menopause

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

Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic Test: Baroreflex sensitivity testingDiagnostic Test: Sympathoexcitatory ManeuversDiagnostic Test: Blood tests

Interventions

Baroreflex sensitivity testingDIAGNOSTIC_TEST

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.

Aim 1: Postmenopausal WomenAim 1: Premenopausal WomenAim 2: Premature/Early MenopauseAim 2: Typical-Age Menopause
Sympathoexcitatory ManeuversDIAGNOSTIC_TEST

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

Aim 1: Postmenopausal WomenAim 1: Premenopausal WomenAim 2: Premature/Early MenopauseAim 2: Typical-Age Menopause
Blood testsDIAGNOSTIC_TEST

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

Aim 1: Postmenopausal WomenAim 1: Premenopausal WomenAim 2: Premature/Early MenopauseAim 2: Typical-Age Menopause
Microneurography to measure muscle sympathetic nerve activity (MSNA)DIAGNOSTIC_TEST

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

Aim 1: Postmenopausal WomenAim 1: Premenopausal WomenAim 2: Premature/Early MenopauseAim 2: Typical-Age Menopause

Eligibility Criteria

Age35 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Two scenarios of recruiting and enrolling premature/early menopausal females have been determined. 1) Enroll participants prior to starting MHT and/or 2) for patients already taking prescribed MHT, a standard protocol has been developed with Dr. Torkelson on guidelines for enrolling these participants. This includes a baseline estradiol (E2) blood draw, then in coordination with the participant and their physician, the participant will stop taking MHT. Estradiol will be tested every two weeks, up to 3 times (6 weeks). When estradiol is \<30 pg/ml for two weeks, participants will be enrolled in the study and can commence MHT immediately upon completion of study visit.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

HypertensionMenopause, Premature

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Manda Keller-Ross, PhD, DPT, PT

CONTACT

612-625-3175kell0529@umn.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2019

First Posted

June 19, 2020

Study Start

October 1, 2019

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Locations

US(1)