Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT05193968

Conditions

Hot Flashes

Menopause

Vasomotor System; Labile

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Accepted

Interventions

Sympathoexcitatory stressors

Sodium Nitroprusside

Acetylcholine

Terbutaline

Norepinephrine

Study Details

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.

Conditions

Hot Flashes

Menopause

Vasomotor System; Labile

Study ID

NCT05193968

Start date

Feb 24, 2022

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Accepted

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

Enrollment

120 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Experimental: Healthy Women Volunteers

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

Interventions

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.

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 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

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

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Pamela A Engrav

507-255-6938engrav.pamela@mayo.edu

Nancy J Meyer

507-255-0913meyer.nancy2@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Pamela A Engrav

507-255-6938

Nancy J Meyer

507-255-0913

More Information

Sponsor

Mayo Clinic

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • Neurovascular function
  • Autonomic function
  • Microvascular Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-06-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.