Examining the cardiovascular effects of hot flushes in postmenopausal women
The Cardiovascular Impact of Hot Flushes
This study tests how hot flushes affect heart and breathing responses in postmenopausal women to see if symptoms and body fat impact these effects.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05251324 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the physiological responses during hot flushes in postmenopausal women. It will utilize a temperature-controlled heating pad to induce hot flushes and assess cardiovascular and respiratory responses in symptomatic versus asymptomatic women. The study will also explore the influence of body fat percentage on the severity and frequency of hot flushes. The findings could provide insights into the cardiovascular risks associated with vasomotor symptoms in postmenopausal women.
Who should consider this trial
Good fit: Ideal candidates are postmenopausal women who have not started or will discontinue hormone therapy during the study.
Not a fit: Patients with significant cardiovascular or respiratory conditions, or those using medications that affect heart or blood pressure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the cardiovascular risks linked to hot flushes, potentially leading to better management strategies for postmenopausal women.
How similar studies have performed: While studies on hot flushes and cardiovascular responses exist, this specific approach using a controlled induction method is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Manda Keller-Ross, PhD, DPT, PT — University of Minnesota Medical School Department of Rehabilitation Medicine
- Study coordinator: Manda Keller-Ross, PhD, DPT, PT
- Email: kell0529@umn.edu
- Phone: (612) 625-3175
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.