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Hot Flashes and Neurovascular Function in Women

Hot Flashes and Neurovascular Function in Women

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05193968
Enrollment
120
Registered
2022-01-18
Start date
2022-02-24
Completion date
2026-12-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hot Flashes, Menopause, Vasomotor System; Labile

Keywords

Neurovascular function, Autonomic function, Microvascular Function

Brief summary

Women who experience hot flashes are at greater risk for hypertension and other cardiovascular disease. Neurovascular control mechanisms are likely to play an important role in this relationship. As such, these studies are designed to provide a major step forward in understanding the link between hot flashes and neurovascular dysfunction and, by extension, cardiovascular disease in women.

Interventions

OTHERSympathoexcitatory stressors

Muscle sympathetic nerve activity will be measured continuously at baseline and in response to sympathoexcitatory stressors, including a Valsalva maneuver, isometric handgrip exercise, a cold pressor test, and stepped hypercapnia.

DRUGSodium Nitroprusside

Sodium nitroprusside, used to test endothelium-independent vasodilation, will be infused through a brachial artery catheter at 0.25, 0.5, 1.0 and 2.0 ug/100ml tissue/min.

DRUGAcetylcholine

Acetylcholine, used to test endothelium-dependent vasodilation, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 μg/100ml tissue/min

Terbutaline, a β2-Adrenergic selective agonist, will be infused through a brachial artery catheter at 0.1, 0.5, 1.0, and 2.0 μg/100ml tissue/min.

DRUGNorepinephrine

Norepinephrine, an α-adrenergic vasoconstricting agent, will be infused through a brachial artery catheter at 1.0, 2.0, 4.0, and 8.0 ng/100ml tissue/min

Sponsors

Mayo Clinic
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Non-smokers. * Non-obese. * Have at least one ovary. * Free from cardiovascular disease. * Not taking medications influencing cardiovascular function.

Exclusion criteria

\- None.

Design outcomes

Primary

MeasureTime frameDescription
Compare microvascular function in women with low and high frequency hot flashesContinuous measurement of vascular conductance during infusion of each drug- 3min at baseline and at each drug dose (~60min total of continuous forearm vascular conductance measurements)Change in forearm vascular conductance with intra-arterial drug infusions. Vascular conductance is an index of vascular tone and is assessed using a technique called venous occlusion plethysmography
Compare sympathetic function in women with low and high frequency hot flashesContinuous measurement of muscle sympathetic nerve activity at rest and in response to stressors (~75min of continuous data collection once a sympathetic nerve signal is found)Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.

Countries

United States

Contacts

CONTACTPamela A Engrav
engrav.pamela@mayo.edu507-255-6938
CONTACTNancy J Meyer
meyer.nancy2@mayo.edu507-255-0913
PRINCIPAL_INVESTIGATORSarah Baker, PhD

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026