NCT04439370

Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 35 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Aim One: Determine mechanisms driving autonomic dysregulation of blood pressure (BP) in premature and early menopausal women. Because sympathetic activity and baroreflex function are important contributors for autonomic support of BP regulation, these two mechanisms will be assessed in premature and early menopausal women who are ≤49 yr old. To specifically identify the influence of menopause, these women will be compared to age-matched premenopausal women. The primary hypothesis is that there is greater resting sympathetic activity and blunted baroreflex function in premature and early menopausal women compared with age-matched premenopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early menopausal compared with age-matched premenopausal women when the sympathetic nervous system is challenged with a stressor. Aim Two: Determine mechanisms driving autonomic dysregulation of BP in older menopausal women. Because older age contributes to risk of CVD, it is imperative to assess the long-term effects of premature and early menopause in older (≥50 yr) women. To determine the impact of the premature loss of sex hormones on cardiovascular physiology, women whom have lived without functioning ovaries for \>10 yr will be compared to age-matched women who entered menopause at a typical age. The primary hypothesis is that resting sympathetic activity is greater and baroreflex function is attenuated in women who experience premature or early menopause compared with typically-aged menopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early compared with typically-aged menopausal women when the sympathetic nervous system is challenged with a stressor.

Conditions

• Hypertension
• Menopause, Premature
• Menopause
• Blood Pressure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Microneurography to measure muscle sympathetic nerve activity (MSNA)	Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
DIAGNOSTIC_TEST	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.
DIAGNOSTIC_TEST	Sympathoexcitatory Maneuvers	Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
DIAGNOSTIC_TEST	Blood tests	Serum FSH, estrogen, progesterone, and testosterone will be measured

Timeline

• Start date: 2019-10-01
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2020-06-19
• Last updated: 2026-01-08

Locations

1 site across 1 country: United States