Leiomyoma Clinical Trial
Official title:
Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata
The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.
The investigators are inviting women, 25-50 years old, who have not gone through menopause to
participate in this study. The investigators are looking for some women with uterine fibroids
and some without uterine fibroids based on ultrasound or MRI. If the patients have not had a
recent ultrasound or MRI of the uterus, a physician can provide one.
Individuals cannot participate if they have high blood pressure, diabetes, or disease in the
kidneys, lungs, or blood vessels. Also, individuals who smoke, have high cholesterol, or are
obese (BMI is higher than 30) cannot participate. Certain medications, including high blood
pressure medications, beta-blockers and anti-depressants, will also limit potential patient
participation. The investigators would be happy to review medications for potential
participants.
Screen Day:
One of the members of the research team will review the study and the informed consent
document with the patient. The patient will have their height, weight, blood pressure, pulse
and respirations measured. The patient will also complete three questionnaires. If the
patient has not had an ultrasound of the uterus in the last 12 months, a physician will
complete one for her.
Study Day:
The patient will need to fast overnight (no eating or drinking). The investigators will draw
a blood sample and then do a series of tests on the participant's blood vessels. For some of
the tests, medication will be given through an IV. The investigators will also test nerve
activity in the nerve on the outer aspect of the leg.
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