Health TrialsbyHealthPanel

Hot Flashes and Neurovascular Function in Women

ConditionsHot FlashesMenopauseVasomotor System; Labile
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Non-smokers.

Non-obese.

Have at least one ovary.

Free from cardiovascular disease.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Sympathoexcitatory stressors

    Other intervention

    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

    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

    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

    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

    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

Treatment groups

120 Participants
are divided into 1 treatment group
Group A: Experimental: Healthy Women VolunteersOther 5 interventions

Trial outcomes

Primary outcomes

1

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

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)
2

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

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

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)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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