Hot Flashes and Neurovascular Function in Women

Not Applicable

Recruiting

• Conditions: Hot Flashes; Menopause; Vasomotor System; Labile
• Interventions: Other: Sympathoexcitatory stressors; Drug: Sodium Nitroprusside; Drug: Acetylcholine; Drug: Terbutaline; Drug: Norepinephrine

• Registration Number: NCT05193968
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-18
• Study Start: 2022-02-24
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-22
• Last Update Posted: 2024-05-24
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

• None.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental: Healthy Women Volunteers	Sympathoexcitatory stressors	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
Experimental: Healthy Women Volunteers	Sodium Nitroprusside	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
Experimental: Healthy Women Volunteers	Acetylcholine	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
Experimental: Healthy Women Volunteers	Terbutaline	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
Experimental: Healthy Women Volunteers	Norepinephrine	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

Primary Outcome Measures

Name	Time	Method
Compare microvascular function in women with low and high frequency hot flashes	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
Compare sympathetic function in women with low and high frequency hot flashes	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States