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.

Trial Health

On Track

Trial Health Score

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

Enrollment

120

participants targeted

Target at P50-P75 for not_applicable

Timeline

7mo left

Started Feb 2022

Longer than P75 for not_applicable

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

4.8 years study duration

Study Progress88%

Feb 2022Dec 2026

First Submitted

Initial submission to the registry

November 15, 2021

Completed

2 months until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed

1 month until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

June 3, 2025

Status Verified

May 1, 2025

Enrollment Period

4.8 years

First QC Date

November 15, 2021

Last Update Submit

May 28, 2025

Conditions

Hot Flashes Menopause Vasomotor System; Labile

Keywords

Neurovascular functionAutonomic functionMicrovascular Function

Outcome Measures

Primary Outcomes (2)

Compare microvascular function in women with low and high frequency hot flashes
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
Continuous 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)
Compare sympathetic function in women with low and high frequency hot flashes
Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.
Continuous 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)

Study Arms (1)

Experimental: Healthy Women Volunteers

OTHER

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

Other: Sympathoexcitatory stressorsDrug: Sodium NitroprussideDrug: AcetylcholineDrug: TerbutalineDrug: Norepinephrine

Interventions

Sympathoexcitatory stressorsOTHER

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.

Also known as: Valsalva maneuver, handgrip exercise, ice water, and hypercapnia