Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Baseline systolic, diastolic, and mean blood pressures
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women 25-50 years old
- •Premenopausal
排除标准
- •Postmenopausal
- •Pregnant or currently breastfeeding
- •Using blood pressure medications or anti-depression medications
- •High blood pressure
- •Disease in the kidneys, lungs, or blood vessels
- •Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.)
- •High cholesterol
- •BMI higher than 30
研究组 & 干预措施
Women with uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Brachial artery catheter (Device)
Women with uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Acetylcholine (Drug)
Women with uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Nitroprusside (Drug)
Women with uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Norepinephrine (Drug)
Women with uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Nitroprusside and phenylephrine (Drug)
Women without uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Brachial artery catheter (Device)
Women without uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Acetylcholine (Drug)
Women without uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Nitroprusside (Drug)
Women without uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Norepinephrine (Drug)
Women without uterine fibroids
- Brachial artery catheter
- Acetylcholine
- Nitroprusside
- Norepinephrine
- Nitroprusside and phenylephrine
干预措施: Nitroprusside and phenylephrine (Drug)
结局指标
主要结局
Baseline systolic, diastolic, and mean blood pressures
时间窗: One day (study day)
Baseline sympathetic nerve activity
时间窗: One day (study day)
Nerve "burst" activity will be measured across 10 minutes.
次要结局
- Changes in forearm blood flow levels in response to nitroprusside infusion(One day (study day))
- Changes in forearm blood flow levels in response to norepinephrine infusion(One day (study day))
- Change in blood pressure in response to infusions of nitroprusside and phenylephrine(One day (study))
- Changes in forearm blood flow levels in response to acetylcholine infusion(One day (study day))
- Pulse wave velocity (an index of vessel stiffness)(One day (study day))