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Vascular Function and Uterine Fibroids

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Leiomyoma

Intervention: Brachial artery catheter (Device); Acetylcholine (Drug); Nitroprusside (Drug); Norepinephrine (Drug); Nitroprusside and phenylephrine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Mayo Clinic

Official(s) and/or principal investigator(s):
Michael J Joyner, M.D., Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Pamela A Engrav, Phone: 507-255-6938, Email: engrav.pamela@mayo.edu

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.

Clinical Details

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

Study design: Observational Model: Case Control, Time Perspective: Cross-Sectional

Primary outcome:

Baseline systolic, diastolic, and mean blood pressures

Baseline sympathetic nerve activity

Secondary outcome:

Changes in forearm blood flow levels in response to acetylcholine infusion

Changes in forearm blood flow levels in response to nitroprusside infusion

Changes in forearm blood flow levels in response to norepinephrine infusion

Change in blood pressure in response to infusions of nitroprusside and phenylephrine

Pulse wave velocity (an index of vessel stiffness)

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.

Eligibility

Minimum age: 25 Years. Maximum age: 50 Years. Gender(s): Female.

Criteria:

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

Locations and Contacts

Pamela A Engrav, Phone: 507-255-6938, Email: engrav.pamela@mayo.edu

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Pamela A Engrav, Phone: 507-255-6938, Email: engrav.pamela@mayo.edu
Michael J Joyner, M.D., Principal Investigator
Additional Information

Starting date: April 2013
Last updated: August 19, 2015

Page last updated: August 23, 2015

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