HypertensionNCT04439370
Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
An observational study of Hypertension and Menopause, Premature, run by University of Minnesota at 1 site in United States.
Trial summary
This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Read more about this study
- Who is it for?
- Ages 35 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Menopause, Premature, Menopause
- What is being tested?
- Microneurography to measure muscle sympathetic nerve activity (MSNA), Baroreflex sensitivity testing and Sympathoexcitatory Maneuvers
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two scenarios of recruiting and enrolling premature/early menopausal females have been determined. 1) Enroll participants prior to starting MHT and/or 2) for patients already taking prescribed MHT, a standard protocol has been developed with Dr. Torkelson on guidelines for enrolling these participants. This includes a baseline estradiol (E2) blood draw, then in coordination with the participant and their physician, the participant will stop taking MHT. Estradiol will be tested every two weeks, up to 3 times (6 weeks). When estradiol is <30 pg/ml for two weeks, participants will be enrolled in the study and can commence MHT immediately upon completion of study visit.
Who may be able to join
- Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
- Premenopausal 35-49 years of age
- Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
- Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Who cannot join
- Current nicotine/tobacco use within the past six months
- Are diabetic or asthmatic
- Have diagnosed significant carotid stenosis
- Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
- Have existing metabolic or endocrine abnormities
- Take any heart/blood pressure medications that are determined to interfere with study outcomes
Show all 9Show fewer
- IF the participant is premenopausal AND currently taking OC or other exogenous steroids that are determined to interfere with study outcomes
- Females who classify as having early or premature menopause AND are not willing to discontinue OC or MHT in order to complete the study
- Are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Manda Keller-Ross, PhD, DPT, PT, 612-625-3175, kell0529@umn.edu
About this study
This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Specifically, aim one will determine mechanisms driving autonomic dysregulation of BP in premature and early menopausal women and aim two will determine mechanisms driving autonomic dysregulation of BP in older menopausal women. The study design outlined below will permit testing of aim one and aim two.
Read the detailed description
Aim One: Determine mechanisms driving autonomic dysregulation of blood pressure (BP) in premature and early menopausal women. Because sympathetic activity and baroreflex function are important contributors for autonomic support of BP regulation, these two mechanisms will be assessed in premature and early menopausal women who are ≤49 yr old. To specifically identify the influence of menopause, these women will be compared to age-matched premenopausal women. The primary hypothesis is that there is greater resting sympathetic activity and blunted baroreflex function in premature and early menopausal women compared with age-matched premenopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early menopausal compared with age-matched premenopausal women when the sympathetic nervous system is challenged with a stressor.
Aim Two: Determine mechanisms driving autonomic dysregulation of BP in older menopausal women. Because older age contributes to risk of CVD, it is imperative to assess the long-term effects of premature and early menopause in older (≥50 yr) women. To determine the impact of the premature loss of sex hormones on cardiovascular physiology, women whom have lived without functioning ovaries for >10 yr will be compared to age-matched women who entered menopause at a typical age. The primary hypothesis is that resting sympathetic activity is greater and baroreflex function is attenuated in women who experience premature or early menopause compared with typically-aged menopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early compared with typically-aged menopausal women when the sympathetic nervous system is challenged with a stressor.
- Conditions
- Hypertension, Menopause, Premature, Menopause, Blood Pressure
- Being tested
- Microneurography to measure muscle sympathetic nerve activity (MSNA), Baroreflex sensitivity testing, Sympathoexcitatory Maneuvers, Blood tests
- Medical subject headings
- Hypertension, Menopause, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneurography to measure muscle sympathetic nerve activity (MSNA)Diagnostic test
Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
Baroreflex sensitivity testingDiagnostic test
Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
Sympathoexcitatory ManeuversDiagnostic test
Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
Blood testsDiagnostic test
Serum FSH, estrogen, progesterone, and testosterone will be measured
| Study group | Role | What they receive |
|---|---|---|
| Aim 1: Postmenopausal Women | Participants in this group are postmenopausal women. Receives: Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA); Diagnostic Test: Baroreflex sensitivity testing; Diagnostic Test: Sympathoexcitatory Maneuvers; Diagnostic Test: Blood tests | |
| Aim 1: Premenopausal Women | Participants in this group are premenopausal women. Receives: Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA); Diagnostic Test: Baroreflex sensitivity testing; Diagnostic Test: Sympathoexcitatory Maneuvers; Diagnostic Test: Blood tests | |
| Aim 2: Premature/Early Menopause | Participants in this group women who experienced premature or early menopause. Receives: Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA); Diagnostic Test: Baroreflex sensitivity testing; Diagnostic Test: Sympathoexcitatory Maneuvers; Diagnostic Test: Blood tests | |
| Aim 2: Typical-Age Menopause | Participants in this group are women who experienced menopause at a typical age. Receives: Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA); Diagnostic Test: Baroreflex sensitivity testing; Diagnostic Test: Sympathoexcitatory Maneuvers; Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute)
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per minute.
Measured: 3 hours
Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats)
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per 100 heart beats.
Measured: 3 hours
Cardiac baroreflex sensitivity
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units as ms/mmHg.
Measured: 3 hours
Sympathetic baroreflex sensitivity
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units of MSNA bursts/mmHg.
Measured: 3 hours
Systolic Blood Pressure (mmHg)
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Measured: 3 hours
Diastolic Blood Pressure (mmHg)
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Measured: 3 hours
Mean Arterial Blood Pressure (mmHg)
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Measured: 3 hours
Heart Rate (beats/min)
Heart rate will be measured with a three-lead electrocardiogram (ECG) and reported in units of beats/min.
Measured: 3 hours
Secondary outcomes (12)
Respiratory Rate (breaths/min)
Respiratory rate will be measured with a belt placed around the stomach and reported in units of breaths-per-minute.
Measured: 3 hours
Heart Rate Variability (frequency)
Heart rate variability will be measured using electrocardiogram and reported in units of Hertz.
Measured: 3 hours
Heart Rate Variability (time)
Heart rate variability will be measured using electrocardiogram and reported in units of milliseconds.
Measured: 3 hours
Borg Rating of Perceived Exertion
Participants will be asked to rate their perceived exertion using the Borg Rating of Perceived Exertion scale. Scores range from 6-20 with higher scores indicating greater exertion.
Measured: 3 hours
Numerical Pain Scale Rating
Participants will be asked to rate pain on a scale from 0 to 10. Higher scores indicate greater pain.
Measured: 3 hours
Blood Levels: Estrogens-E1
Serum concentration of estrogen-E1 will be reported in units of ng/ml.
Measured: 75 minutes
Blood Levels: Estrogen-E2
Serum concentration of estrogen-E2 will be reported in units of ng/ml.
Measured: 75 minutes
Blood Levels: Progesterone
Serum concentration of progesterone will be reported in units of ng/ml.
Measured: 75 minutes
Blood Levels: Testosterone
Serum concentration of testosterone will be reported in units of ng/ml.
Measured: 75 minutes
Blood Levels: Follicle-Stimulating Hormone (FSH)
Serum concentration of FSH will be reported in units of IU/L.
Measured: 75 minutes
Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO)
This test involves holding a hand grip device at 30% of the participant's maximum hand grip strength until they fatigue. At the end of this test a blood pressure cuff is inflated for two minutes. The outcome measurements are the total change in systolic, diastolic and mean blood pressure from rest as well as how much blood pressure changes every 15 seconds. The measurement units are the change in blood pressure in mmHg.
Measured: 3 hours
Cold Pressor Test
The cold pressor test is done by placing the participant's hand in a bucket of ice-cold water for 2 minutes. The outcome measurements are the total change in systolic, diastolic and mean blood pressure from rest as well as how much blood pressure changes every 15 seconds. The measurement units are the change in blood pressure in mmHg.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start1 Oct 2019
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439370
- Sponsor's protocol ID
- PT-2018-27097
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2019
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
- ClinicalTrials.gov ID
- NCT04439370
- Acronym / sponsor ID
- PT-2018-27097
- Conditions
- Hypertension, Menopause, Premature, Menopause, Blood Pressure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a cross-sectional study in which the investigators will determine the impact of premature/early menopause on MSNA, BP and baroreflex sensitivity in younger (≤49 yr old) and older (≥50 yr old) women. Specifically, aim one will determine mechanisms driving autonomic dysregulation of BP in premature and early menopausal women and aim two will determine mechanisms driving autonomic dysregulation of BP in older menopausal women. The study design outlined below will permit testing of aim one and aim two.
Detailed description
Aim One: Determine mechanisms driving autonomic dysregulation of blood pressure (BP) in premature and early menopausal women. Because sympathetic activity and baroreflex function are important contributors for autonomic support of BP regulation, these two mechanisms will be assessed in premature and early menopausal women who are ≤49 yr old. To specifically identify the influence of menopause, these women will be compared to age-matched premenopausal women. The primary hypothesis is that there is greater resting sympathetic activity and blunted baroreflex function in premature and early menopausal women compared with age-matched premenopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early menopausal compared with age-matched premenopausal women when the sympathetic nervous system is challenged with a stressor.
Aim Two: Determine mechanisms driving autonomic dysregulation of BP in older menopausal women. Because older age contributes to risk of CVD, it is imperative to assess the long-term effects of premature and early menopause in older (≥50 yr) women. To determine the impact of the premature loss of sex hormones on cardiovascular physiology, women whom have lived without functioning ovaries for >10 yr will be compared to age-matched women who entered menopause at a typical age. The primary hypothesis is that resting sympathetic activity is greater and baroreflex function is attenuated in women who experience premature or early menopause compared with typically-aged menopausal women. The secondary hypothesis is that BP and sympathetic reactivity will be greater in premature and early compared with typically-aged menopausal women when the sympathetic nervous system is challenged with a stressor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Aim 1: Postmenopausal Women | – | Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood testsParticipants in this group are postmenopausal women. |
| Aim 1: Premenopausal Women | – | Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood testsParticipants in this group are premenopausal women. |
| Aim 2: Premature/Early Menopause | – | Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood testsParticipants in this group women who experienced premature or early menopause. |
| Aim 2: Typical-Age Menopause | – | Diagnostic Test: Microneurography to measure muscle sympathetic nerve activity (MSNA), Diagnostic Test: Baroreflex sensitivity testing, Diagnostic Test: Sympathoexcitatory Maneuvers, Diagnostic Test: Blood testsParticipants in this group are women who experienced menopause at a typical age. |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two scenarios of recruiting and enrolling premature/early menopausal females have been determined. 1) Enroll participants prior to starting MHT and/or 2) for patients already taking prescribed MHT, a standard protocol has been developed with Dr. Torkelson on guidelines for enrolling these participants. This includes a baseline estradiol (E2) blood draw, then in coordination with the participant and their physician, the participant will stop taking MHT. Estradiol will be tested every two weeks, up to 3 times (6 weeks). When estradiol is <30 pg/ml for two weeks, participants will be enrolled in the study and can commence MHT immediately upon completion of study visit.
Key inclusion criteria (4 listed)
- Aged 35-49 or 50-70 years of age who experienced premature (<40) or early (≤45) menopause
- Premenopausal 35-49 years of age
- Typical-age menopause (i.e., after 45 years of age), who are between 50-70 years old
- Menopause will be confirmed by subject report of amenorrhea for 12 months and serum FSH of >30 mIU/mL
Key exclusion criteria (9 listed)
- Current nicotine/tobacco use within the past six months
- Are diabetic or asthmatic
- Have diagnosed significant carotid stenosis
- Have a history of significant autonomic dysfunction, heart disease, respiratory disease or a severe neurologic condition such as stroke or traumatic brain injury.
- Have existing metabolic or endocrine abnormities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneurography to measure muscle sympathetic nerve activity (MSNA)Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves | Diagnostic test | Aim 1: Postmenopausal Women, Aim 1: Premenopausal Women, Aim 2: Premature/Early Menopause, Aim 2: Typical-Age Menopause |
| Baroreflex sensitivity testingTwo arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers. | Diagnostic test | Aim 1: Postmenopausal Women, Aim 1: Premenopausal Women, Aim 2: Premature/Early Menopause, Aim 2: Typical-Age Menopause |
| Sympathoexcitatory ManeuversCold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed | Diagnostic test | Aim 1: Postmenopausal Women, Aim 1: Premenopausal Women, Aim 2: Premature/Early Menopause, Aim 2: Typical-Age Menopause |
| Blood testsSerum FSH, estrogen, progesterone, and testosterone will be measured | Diagnostic test | Aim 1: Postmenopausal Women, Aim 1: Premenopausal Women, Aim 2: Premature/Early Menopause, Aim 2: Typical-Age Menopause |
Primary outcome
Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute)
Time frame: 3 hours
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per minute.
Muscle Sympathetic Nerve Activity (MSNA) (bursts/100 heart beats)
Time frame: 3 hours
Muscle sympathetic nerve activity (MSNA) is a measurement of sympathetic activity. This is measured by two small needles are inserted behind or on the side of the knee, one needle is an acupuncture needle and one needle is a small recording microelectrode (same size as the acupuncture needle). Outcome will be reported in units of bursts per 100 heart beats.
Cardiac baroreflex sensitivity
Time frame: 3 hours
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units as ms/mmHg.
Sympathetic baroreflex sensitivity
Time frame: 3 hours
Baroreflex sensitivity will be derived from electrocardiogram measurements and blood pressure measurements during the baseline rest period and by performing a modified valsalva maneuver which involves exhaling against 30-40 mmHg of pressure over 15 seconds after a normal inhalation. Outcome will be reported in units of MSNA bursts/mmHg.
Systolic Blood Pressure (mmHg)
Time frame: 3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Diastolic Blood Pressure (mmHg)
Time frame: 3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Mean Arterial Blood Pressure (mmHg)
Time frame: 3 hours
Blood pressure is measured using a non-invasive blood pressure cuff secured to the middle or ring finger and reported in units of mmHg.
Heart Rate (beats/min)
Time frame: 3 hours
Heart rate will be measured with a three-lead electrocardiogram (ECG) and reported in units of beats/min.
12 secondary outcomes
Respiratory Rate (breaths/min)
Time frame: 3 hours
Heart Rate Variability (frequency)
Time frame: 3 hours
Heart Rate Variability (time)
Time frame: 3 hours
Borg Rating of Perceived Exertion
Time frame: 3 hours
Numerical Pain Scale Rating
Time frame: 3 hours
Blood Levels: Estrogens-E1
Time frame: 75 minutes
Blood Levels: Estrogen-E2
Time frame: 75 minutes
Blood Levels: Progesterone
Time frame: 75 minutes
Blood Levels: Testosterone
Time frame: 75 minutes
Blood Levels: Follicle-Stimulating Hormone (FSH)
Time frame: 75 minutes
Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO)
Time frame: 3 hours
Cold Pressor Test
Time frame: 3 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Menopause, Premature, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manda Keller-Ross, PhD, DPT, PT (612-625-3175, kell0529@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Sympathetic Nerve Activity (MSNA) (bursts per minute) (time frame: 3 hours). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.