Vascular Function and Uterine Fibroids

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata

Conditions
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Leiomyoma

Intervention / Treatment
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* Device: Brachial artery catheter
* Drug: Acetylcholine
* Drug: Nitroprusside
* Drug: Norepinephrine
* Drug: Nitroprusside and phenylephrine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women 25-50 years old Premenopausal Exclusion Criteria: Postmenopausal Pregnant or currently breastfeeding Using blood pressure medications or anti-depression medications High blood pressure Diabetes Disease in the kidneys, lungs, or blood vessels Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.) Smoker High cholesterol BMI higher than 30

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women with uterine fibroids<br>Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine | Device: Brachial artery catheter<br>* A catheter will be placed in the brachial artery by a physician on the study day.<br>Drug: Acetylcholine<br>* Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Nitroprusside<br>* Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Norepinephrine<br>* Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Nitroprusside and phenylephrine<br>* A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.<br>|
| Women without uterine fibroids<br>Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine | Device: Brachial artery catheter<br>* A catheter will be placed in the brachial artery by a physician on the study day.<br>Drug: Acetylcholine<br>* Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Nitroprusside<br>* Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Norepinephrine<br>* Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.<br>Drug: Nitroprusside and phenylephrine<br>* A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline systolic, diastolic, and mean blood pressures |  | One day (study day) | 
| Baseline sympathetic nerve activity | Nerve burst activity will be measured across 10 minutes. | One day (study day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in forearm blood flow levels in response to acetylcholine infusion |  | One day (study day) | 
| 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 | An infusion of nitroprusside will be given, followed by an infusion of phenylephrine one minute later. | One day (study) | 
| Pulse wave velocity (an index of vessel stiffness) |  | One day (study day) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autonomic nervous system, Blood pressure, Blood vessels, Physiological effects of drugs, Vascular stiffness