The Cardiovascular Impact of Hot Flushes

NCT05251324 | Recruiting

• 1 other identifier: STUDY00013742
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hot Flashes; Menopause

Keywords

Menopause

Outcome Measures

Primary Outcomes (5)

• Systolic Blood pressure (mmHg)

  Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.

  3 hours

• Diastolic Blood pressure

  Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.

  3 hours

• Mean arterial Blood pressure

  Blood pressure will be measured using a non-invasive blood pressure cuff and measured in units of mmHG and assessed at Visit 2.

  3 hours

• Skin conductance

  Skin conductance is measured using galvanic skin response and is measured in umho. Skin conductance will be assessed at Visit 2.

  3 hours

• Skin temperature

  Skin temperature will be measured by a skin thermometer and reported in °C or °F as an objective measure of hot flushes. Skin temperature will be assessed at Visit 2.

  3 hours

Secondary Outcomes (15)

• Heart rate

  3 hours

• Respiratory rate

  3 hours

• Heart rate variability

  3 hours

• Numerical pain rating scale

  3 hours

• Blood levels of estradiol (E2)

  3 hours

Study Arms (2)

Participants With Hot Flushes (at least 3 per day)

At Visit 1, participants will complete informed consent, questionnaires regarding medical history, physical activity levels, stress and anxiety, menopause symptoms and a hot flush behavior scale. Visit one will be completed remotely using a HIPAA-compliant online platform or over the phone. At Visit 2, baseline measurements will be recorded for two hours and spontaneous hot flushes will be detected. Participants will then have a temperature-controlled, water-circulating heating pad at a consistent temperature of 107˚F placed on their torso for 30 min, followed by five min of recovery. This will be followed by a blood draw to measure sex hormones. At either Visit 2 or a separate visit, participants will have a dual energy x-ray absorptiometry scan for a body composition assessment. For participants taking prescribed MHT, a standard protocol for enrollment and they may complete up to six study visits.

Other: Hot Flush Induction

Participants Without Hot Flushes

At Visit 1, participants will complete informed consent, questionnaires regarding medical history, physical activity levels, stress and anxiety, menopause symptoms and a hot flush behavior scale. Visit one will be completed remotely using a HIPAA-compliant online platform or over the phone. At Visit 2, baseline measurements will be recorded for two hours and spontaneous hot flushes will be detected. Participants will then have a temperature-controlled, water-circulating heating pad at a consistent temperature of 107˚F placed on their torso for 30 min, followed by five min of recovery. This will be followed by a blood draw to measure sex hormones. At either Visit 2 or a separate visit, participants will have a dual energy x-ray absorptiometry scan for a body composition assessment. For participants taking prescribed MHT, a standard protocol for enrollment and they may complete up to six study visits.

Other: Hot Flush Induction

Interventions

Hot Flush Induction OTHER

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.

Participants With Hot Flushes (at least 3 per day); Participants Without Hot Flushes

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

40-70-year-old postmenopausal women who experience hot flushes and those who do not. Women who have not started hormone therapy and/or will discontinue hormone therapy for the duration of the study.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Hot Flashes

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Manda Keller-Ross, PhD, DPT, PT

  University of Minnesota Medical School Department of Rehabilitation Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manda Keller-Ross, PhD, DPT, PT

CONTACT

(612) 625-3175; kell0529@umn.edu

William Stokes

CONTACT

(443) 801-8778; stoke123@umn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 22, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)