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NCT Number: NCT05193968

Hot Flashes and Neurovascular Function in Women

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.

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Key information

Conditions

Hot Flashes Menopause Pathological Conditions, Signs and Symptoms Signs and Symptoms Vasomotor System; Labile

Age range

40 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Nancy J Meyer

CONTACT

507-255-0913

Pamela A Engrav

CONTACT

507-255-6938

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None.

Treatment and study plan

Sympathoexcitatory stressors

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.

Other names: Valsalva maneuver, handgrip exercise, ice water, and hypercapnia

Sodium Nitroprusside

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.

Other names: Forearm vascular conductance response to sodium nitroprusside

Acetylcholine

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

Other names: Forearm vascular conductance response to acetylcholine

Terbutaline

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.

Other names: Forearm vascular conductance response to terbutaline

norepinephrine

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

Other names: Forearm vascular conductance response to norepinephrine

Primary outcomes

  1. Compare microvascular function in women with low and high frequency hot flashes

    Time frame: 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)

    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

  2. Compare sympathetic function in women with low and high frequency hot flashes

    Time frame: 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)

    Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy J Meyer

CONTACT

[email protected]

507-255-0913

Pamela A Engrav

CONTACT

[email protected]

507-255-6938

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 18, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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