The Cardiovascular Impact of Hot Flushes
University of Minnesota
60 participants
Mar 1, 2022
OBSERVATIONAL
Conditions
Summary
The overall objective of this study is to examine the physiological responses that occur during a hot flush in postmenopausal women. The following specific aims will be executed to reach the overall objective of this study. Aim 1: To determine if hot flushes can be reliably induced with a temperature-controlled, water- circulating (TCWC) heating pad. Based on previous research, the investigators hypothesize that hot flushes will be inducible with the TCWC in symptomatic women, but not in asymptomatic women. Aim 2: To determine if heat-induced hot flushes in symptomatic women will cause reproducible cardiovascular and respiratory responses. The investigators hypothesize that heat-induced hot flushes produce similar and reproducible cardiovascular and respiratory responses to spontaneous hot flushes. Aim 3: To determine if body fat percentage influences hot flush severity or frequency during spontaneous or induced hot flushes. The investigators hypothesize that women with higher body fat have reduced hot flash severity and frequency.
Eligibility
Inclusion Criteria2
- Postmenopausal (may have or may not have hot flushes)
- Have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study
Exclusion Criteria12
- Reported nicotine/tobacco use within the last six months
- Diabetic or asthmatic
- Diagnosed significant carotid stenosis
- History of significant autonomic dysfunction, heart disease, respiratory disease, or severe neurologic condition such as stroke or traumatic brain injury
- Existing metabolic or endocrine abnormalities
- Use of heart/blood pressure medications that are determined to interfere with study outcomes
- Unwilling to discontinue use of OC (or other hormonal contraceptives, including intrauterine devices or contraceptive implants) and/or MHT
- Pregnant or breastfeeding
- Unwilling or unable to refrain from consuming caffeine or alcohol in the 12 hours before visit two or three
- Unwilling or unable to refrain from vigorous exercise (at least 10 minutes in duration) in the 12 hours before visit two or three
- Unwilling or unable to fast in the eight hours before visit two or three
- Body mass index greater than or equal to 35 kg/m\^3
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Interventions
A temperature-controlled, water-circulating heating pad at a constant temperature of 107˚F will be placed on the participant's torso, a microwaved heating neck pad will be placed on the participant's neck, and two warm balloons will be placed in the participant's hands for 30 min. Subjective (verbal start and end point to be marked on LabChart software) and objective (skin conductance and skin temperature) measures of hot flushes will be recorded.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05251324