The Cardiovascular Impact of Hot Flushes

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05251324
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 70 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
Mar 1, 2022
Status verified
Apr 2026
Primary completion
May 26, 2027
Completion
May 26, 2027

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Systolic Blood pressure (mmHg) [ Time Frame: 3 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Menopause
By specialty
Women's healthFertility
By research site
University of Minnesota· Minneapolis, MN

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