NCT05251324 · University of Minnesota
The Cardiovascular Impact of Hot Flushes
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Minneapolis, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 7, 2026 · Source of record for eligibility and locations