Hot Flashes and Neurovascular Function in Women

May 18, 2023 updated by: Sarah E. Baker, Ph.D., Mayo Clinic
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Contact:
          • Pamela A Engrav
          • Phone Number: 507-255-6938
        • Contact:
          • Nancy J Meyer
          • Phone Number: 507-255-0913

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
Other Names:
  • Valsalva maneuver, handgrip exercise, ice water, and 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.
Other Names:
  • Forearm vascular conductance response to sodium nitroprusside
Drug: 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
Other Names:
  • Forearm vascular conductance response to acetylcholine
Drug: 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.
Other Names:
  • Forearm vascular conductance response to terbutaline
Drug: 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
Other Names:
  • Forearm vascular conductance response to norepinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)

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)
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

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

Investigators

  • Principal Investigator: Sarah Baker, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2022

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 15, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

May 19, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-002638
  • K01HL148144 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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