Health TrialsbyHealthPanel

The Cardiovascular Impact of Hot Flushes

ConditionsHot FlashesMenopause
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age40-70
SponsorUniversity of Minnesota

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Hot Flush Induction

    Other intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Participants With Hot Flushes (at least 3 per day)1 intervention
Group B: Participants Without Hot Flushes1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
3 hours
2

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.

Time frame
3 hours
3

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.

Time frame
3 hours
4

Skin conductance

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

Time frame
3 hours

Secondary outcomes

1

Heart rate

Heart rate will be measured with a three lead electrocardiogram and measured in beats-per minute Heart rate will be assessed at Visit 2.

Time frame
3 hours
2

Respiratory rate

Respiratory rate will be measured a respiratory belt and reported in breaths per minute. Respiratory rate will be assessed at Visit 2.

Time frame
3 hours
3

Heart rate variability

Heart rate will be measured with a three lead electrocardiogram and reported in units of Hertz and milliseconds. Heart rate variability will be assessed at Visit 2.

Time frame
3 hours
4

Numerical pain rating scale

The numerical pain rating scale consists of 1 item with scores ranging from 1-10, where higher scores represent greater pain. The numerical pain rating scale will be assessed at Visit 2.

Time frame
3 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

Source ClinicalTrials.gov
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