Vascular Function and Uterine Fibroids

Leiomyoma Clinical Trial

Official title:

Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123069
• Other study ID #: 13-000596
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: March 1, 2018
• Start date: April 2013
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Leiomyoma

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Female sex hormone levels	Blood samples will be collected to measure levels of estrogen and progesterone.	One day (study day)
Primary	Baseline systolic, diastolic, and mean blood pressures		One day (study day)
Primary	Baseline sympathetic nerve activity	Nerve "burst" activity will be measured across 10 minutes.	One day (study day)
Secondary	Changes in forearm blood flow levels in response to acetylcholine infusion		One day (study day)
Secondary	Changes in forearm blood flow levels in response to nitroprusside infusion		One day (study day)
Secondary	Changes in forearm blood flow levels in response to norepinephrine infusion		One day (study day)
Secondary	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)
Secondary	Pulse wave velocity (an index of vessel stiffness)		One day (study day)