The Cardiovascular Impact of Hot Flushes (NCT05251324) | Clinical Trial Compass
RecruitingNot Applicable
The Cardiovascular Impact of Hot Flushes
United States60 participantsStarted 2022-03-01
Plain-language 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.
Who can participate
Age range
40 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.