Clinical trial
Hot Flashes and Neurovascular Function in Women
Name
19-002638
Description
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.
Trial arms
Trial start
2022-02-24
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Recruiting
Treatment
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.
Arms:
Experimental: Healthy Women Volunteers
Other names:
Valsalva maneuver, handgrip exercise, ice water, and 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.
Arms:
Experimental: Healthy Women Volunteers
Other names:
Forearm vascular conductance response to sodium nitroprusside
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
Arms:
Experimental: Healthy Women Volunteers
Other names:
Forearm vascular conductance response to acetylcholine
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.
Arms:
Experimental: Healthy Women Volunteers
Other names:
Forearm vascular conductance response to terbutaline
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
Arms:
Experimental: Healthy Women Volunteers
Other names:
Forearm vascular conductance response to norepinephrine
Size
120
Primary endpoint
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)
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)
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-05-24
1 organization
4 products
3 indications
Organization
Mayo ClinicProduct
Sodium NitroprussideIndication
Hot FlashesIndication
MenopauseIndication
Vasomotor SystemProduct
AcetylcholineProduct
TerbutalineProduct
Norepinephrine