Hot Flashes and Neurovascular Function in Women

What this trial studies

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 in scope

• Hot Flashes
• Menopause
• Vasomotor System; Labile

Interventions

• 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.
• 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

Who can join

Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.

Inclusion criteria

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

Exclusion criteria

• \- None.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2022-02-24
• Primary completion: 2026-12
• Last update posted: 2025-06-03
• First posted: 2022-01-18

Sponsor & contact

Lead sponsor: Mayo Clinic (Other)

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

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• 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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.