Hot Flashes and Neurovascular Function in Women

NCT ID: NCT05193968

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-24

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hot Flashes Menopause Vasomotor System; Labile

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Experimental: Healthy Women Volunteers

Hot Flash frequency will be assessed in the study subjects during a screening period. Participants can then chose to participate 1 or 2 study visits- Protocol 1: Microvascular function and/or Protocol 2: Autonomic function

Group Type OTHER

Sympathoexcitatory stressors

Intervention Type OTHER

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.

Sodium Nitroprusside

Intervention Type DRUG

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.

Acetylcholine

Intervention Type DRUG

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

Intervention Type DRUG

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.

Norepinephrine

Intervention Type DRUG

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

Interventions

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Sympathoexcitatory 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.

Intervention Type OTHER

Sodium 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.

Intervention Type DRUG

Acetylcholine

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

Intervention Type DRUG

Terbutaline

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.

Intervention Type DRUG

Norepinephrine

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

Intervention Type DRUG

Other Intervention Names

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Valsalva maneuver, handgrip exercise, ice water, and hypercapnia Forearm vascular conductance response to sodium nitroprusside Forearm vascular conductance response to acetylcholine Forearm vascular conductance response to terbutaline Forearm vascular conductance response to norepinephrine

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None.
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Sarah E. Baker, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sarah Baker, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Pamela A Engrav

Role: CONTACT

507-255-6938

Nancy J Meyer

Role: CONTACT

507-255-0913

Facility Contacts

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Pamela A Engrav

Role: primary

507-255-6938

Nancy J Meyer

Role: backup

507-255-0913

Related Links

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Other Identifiers

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K01HL148144

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-002638

Identifier Type: -

Identifier Source: org_study_id

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