Hot Flashes and Neurovascular Function in Women

Menopause Clinical Trial

Official title:

Hot Flashes and Neurovascular Function in Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193968
• Other study ID #: 19-002638
• Secondary ID: K01HL148144
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2022
• Est. completion date: December 2025

Study information

• Verified date: May 2024
• Source: Mayo Clinic
• Contact: Pamela A Engrav
• Phone: 507-255-6938
• Email: engrav.pamela[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Hot Flashes
• Menopause

Intervention

Other:
• 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.

Drug:
• 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.
• 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
• Terbutaline
Terbutaline, a ß2-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
Norepinephrine, an a-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

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)

External Links

•   Mayo Clinic Clinical Trials