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Hot Flashes and Neurovascular Function in Women

Primary Purpose

Hot Flashes, Menopause, Vasomotor System; Labile

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sympathoexcitatory stressors
Sodium Nitroprusside
Acetylcholine
Terbutaline
Norepinephrine
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hot Flashes focused on measuring Neurovascular function, Autonomic function, Microvascular Function

Eligibility Criteria

40 Years - 60 Years (Adult)FemaleAccepts 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.

Sites / Locations

  • Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Experimental: Healthy Women Volunteers

Arm Description

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

Outcomes

Primary Outcome Measures

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
Compare sympathetic function in women with low and high frequency hot flashes
Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.

Secondary Outcome Measures

Full Information

First Posted
November 15, 2021
Last Updated
May 18, 2023
Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05193968
Brief Title
Hot Flashes and Neurovascular Function in Women
Official Title
Hot Flashes and Neurovascular Function in Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hot Flashes, Menopause, Vasomotor System; Labile
Keywords
Neurovascular function, Autonomic function, Microvascular Function

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Healthy Women Volunteers
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Sympathoexcitatory stressors
Other Intervention Name(s)
Valsalva maneuver, handgrip exercise, ice water, and hypercapnia
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sodium Nitroprusside
Other Intervention Name(s)
Forearm vascular conductance response to sodium nitroprusside
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Acetylcholine
Other Intervention Name(s)
Forearm vascular conductance response to acetylcholine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Other Intervention Name(s)
Forearm vascular conductance response to terbutaline
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Forearm vascular conductance response to norepinephrine
Intervention Description
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 Information:
Title
Compare microvascular function in women with low and high frequency hot flashes
Description
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
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)
Title
Compare sympathetic function in women with low and high frequency hot flashes
Description
Muscle Sympathetic Nerve Activity will be directly using a technique called microneurography.
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)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-smokers. Non-obese. Have at least one ovary. Free from cardiovascular disease. Not taking medications influencing cardiovascular function. Exclusion Criteria: - None.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela A Engrav
Phone
507-255-6938
Email
engrav.pamela@mayo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy J Meyer
Phone
507-255-0913
Email
meyer.nancy2@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Baker, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela A Engrav
Phone
507-255-6938
First Name & Middle Initial & Last Name & Degree
Nancy J Meyer
Phone
507-255-0913

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Hot Flashes and Neurovascular Function in Women

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