NCT04439370 Autonomic Regulation of Blood Pressure in Premature and Early Menopausal Women
| NCT ID | NCT04439370 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2019-10-01 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2019-10-01 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04439370 clinical trial?
This trial is open to female participants only, aged 35 Years or older, up to 70 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04439370 currently recruiting?
Yes, NCT04439370 is actively recruiting participants. Contact the research team at kell0529@umn.edu for enrollment information.
Where is the NCT04439370 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT04439370 clinical trial?
NCT04439370 is sponsored by University of Minnesota. The trial plans to enroll 160 participants.