Estrogen Deficiency on Cardiovascular Risk

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how a lack of estrogen affects women’s heart health, specifically looking at blood pressure and nerve activity, as well as how it might influence certain inflammatory markers in the body. Researchers believe that when estrogen levels are low, it may lead to higher blood pressure and increased nerve activity, which can affect heart health. The study is open to women aged 54 to 75 who are healthy and have not had a menstrual period for over a year or have had a hysterectomy.

Participants in this trial can expect to undergo assessments to determine their eligibility and may take part in activities to measure their blood pressure and other health factors. It’s important to know that women with certain health conditions, those taking specific medications, or with a history of certain diseases may not be eligible to participate. The trial is not yet recruiting participants, but it aims to provide valuable insights into how estrogen deficiency could impact heart health in postmenopausal women.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Age 54-75 years
• • Healthy participants who are capable of giving informed consent
• • Classified as postmenopausal or stop having period \>1year or had a full hysterectomy surgery
• • Any race or ethnicity
• • Have satisfactory history and physical exam
• • Free of acute medical conditions
• Exclusion Criteria:
• • \<54 or \>75 years
• • Medications that could alter cardiovascular, thermoregulatory, or peripheral vascular control (e.g. Angiotensin converting enzyme inhibitors, statins, beta blockers, etc.);
• • Self-reported history of long-term menstrual irregularities, vaginal bleeding, or other gynecological conditions that could influence study outcomes
• • Use of hormone therapy during 6 months prior to study enrollment
• • Allergy to latex
• • Current smoker
• • Have any clinically relevant history or the presence of metabolic (e.g., diabetes), respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or other disease or diseases that, in the opinion of the research team, exclude the subject from participation.
• • Presenting with a resting blood pressure of 150/100 or higher
• • Contraindications to a maximal exercise test or an indication for early termination of an exercise test
• • Taking any medications that affect vascular control or autonomic function (e.g. beta blockers, ACE inhibitors, calcium channel blockers, etc.)
• • Contraindications to estrogen patch: include undiagnosed vaginal bleeding; known, suspected, or history of breast cancer; known or suspected E2-sensitive neoplasm; history of deep venous thrombosis or pulmonary embolism; current or recent arterial thromboembolic disease; liver dysfunction and disease; known or suspected pregnancy.
• • Past/current history of venous thromboembolism, hypercoagulation or thrombopenia
• • Past/current history of hormone-responsive cancer
• • Past/current history of endometrial hyperplasia
• • Patient has a recent drug or alcohol abuse history (less than 6 months) or is currently using or abusing excessive alcohol or drugs. Excessive alcohol will be defined as greater than 14 drinks per week.