Vascular Function and Uterine Fibroids

NCT02123069 | Completed

• 1 other identifier: 13-000596
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Leiomyoma

Keywords

Autonomic nervous system; Blood pressure; Blood vessels; Physiological effects of drugs; Vascular stiffness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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)

• Pulse wave velocity (an index of vessel stiffness)

  One day (study day)

Other Outcomes (1)

• Female sex hormone levels

  One day (study day)

Study Arms (2)

Women with uterine fibroids

* Brachial artery catheter * Acetylcholine * Nitroprusside * Norepinephrine * Nitroprusside and phenylephrine

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

Women without uterine fibroids

* Brachial artery catheter * Acetylcholine * Nitroprusside * Norepinephrine * Nitroprusside and phenylephrine

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

Interventions

Brachial artery catheter DEVICE

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

Women with uterine fibroids; Women without uterine fibroids

Acetylcholine DRUG

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.

Women with uterine fibroids; Women without uterine fibroids

Nitroprusside DRUG

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.

Women with uterine fibroids; Women without uterine fibroids

Norepinephrine DRUG

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.

Women with uterine fibroids; Women without uterine fibroids

Nitroprusside and phenylephrine DRUG

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 with uterine fibroids; Women without uterine fibroids

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women, ages 25-50 years old, who have and have not been diagnosed with uterine fibroids. Women will be recruited from Rochester, Minnesota and the surrounding area (including locations in Iowa and Wisconsin). Women eligible to participate will be in good health and not taking medications.

You may qualify if:

• Women 25-50 years old
• Premenopausal

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and serum No DNA extraction from samples is planned.

MeSH Terms

Conditions

Leiomyoma

Interventions

Acetylcholine; Nitroprusside; Norepinephrine; Phenylephrine

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Biogenic Amines; Amines; Organic Chemicals; Ferricyanides; Cyanides; Anions; Ions; Electrolytes; Inorganic Chemicals; Ferric Compounds; Iron Compounds; Hydrogen Cyanide; Nitrogen Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Michael J Joyner, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 25, 2014
• Study Start: April 1, 2013
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-03

Locations

US (1)