Vascular Function and Uterine Fibroids

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT02123069

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Leiomyoma	Device: Brachial artery catheter Drug: Acetylcholine Drug: Nitroprusside Drug: Norepinephrine Drug: Nitroprusside and phenylephrine

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

28 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata

Study Start Date :

Apr 1, 2013

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Women with uterine fibroids Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine	Device: Brachial artery catheter A catheter will be placed in the brachial artery by a physician on the study day. Drug: Acetylcholine 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. Drug: Nitroprusside 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. Drug: Norepinephrine 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. Drug: Nitroprusside and phenylephrine 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.
Women without uterine fibroids Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine	Device: Brachial artery catheter A catheter will be placed in the brachial artery by a physician on the study day. Drug: Acetylcholine 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. Drug: Nitroprusside 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. Drug: Norepinephrine 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. Drug: Nitroprusside and phenylephrine 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.

Arm

Intervention/Treatment

Women with uterine fibroids

Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine

Device: Brachial artery catheter

A catheter will be placed in the brachial artery by a physician on the study day.

Drug: Acetylcholine

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.

Drug: Nitroprusside

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.

Drug: Norepinephrine

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.

Drug: Nitroprusside and phenylephrine

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.

Women without uterine fibroids

Brachial artery catheter Acetylcholine Nitroprusside Norepinephrine Nitroprusside and phenylephrine

Device: Brachial artery catheter

A catheter will be placed in the brachial artery by a physician on the study day.

Drug: Acetylcholine

Drug: Nitroprusside

Drug: Norepinephrine

Drug: Nitroprusside and phenylephrine

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.

Outcome Measures

Primary Outcome Measures

Baseline systolic, diastolic, and mean blood pressures [One day (study day)]
Baseline sympathetic nerve activity [One day (study day)]
Nerve "burst" activity will be measured across 10 minutes.

Secondary Outcome Measures

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 [One day (study)]
An infusion of nitroprusside will be given, followed by an infusion of phenylephrine one minute later.
Pulse wave velocity (an index of vessel stiffness) [One day (study day)]

Other Outcome Measures

Female sex hormone levels [One day (study day)]
Blood samples will be collected to measure levels of estrogen and progesterone.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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