Vascular Function and Uterine Fibroids

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Michael J. Joyner, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02123069
First received: April 16, 2014
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Leiomyoma
Device: Brachial artery catheter
Drug: Acetylcholine
Drug: Nitroprusside
Drug: Norepinephrine
Drug: Nitroprusside and phenylephrine

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Baseline systolic, diastolic, and mean blood pressures [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
  • Baseline sympathetic nerve activity [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
    Nerve "burst" activity will be measured across 10 minutes.


Secondary Outcome Measures:
  • Changes in forearm blood flow levels in response to acetylcholine infusion [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
  • Changes in forearm blood flow levels in response to nitroprusside infusion [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
  • Changes in forearm blood flow levels in response to norepinephrine infusion [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
  • Change in blood pressure in response to infusions of nitroprusside and phenylephrine [ Time Frame: One day (study) ] [ Designated as safety issue: No ]
    An infusion of nitroprusside will be given, followed by an infusion of phenylephrine one minute later.

  • Pulse wave velocity (an index of vessel stiffness) [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Female sex hormone levels [ Time Frame: One day (study day) ] [ Designated as safety issue: No ]
    Blood samples will be collected to measure levels of estrogen and progesterone.


Biospecimen Retention:   Samples With DNA

Whole blood and serum

No DNA extraction from samples is planned.


Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   25 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02123069

Contacts
Contact: Pamela A Engrav 507-255-6938 engrav.pamela@mayo.edu
Contact: Ronee E Harvey 507-255-1452 harvey.ronee@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Pamela A Engrav    507-255-6938    engrav.pamela@mayo.edu   
Principal Investigator: Michael J Joyner, M.D.         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Michael J Joyner, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Michael J. Joyner, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02123069     History of Changes
Other Study ID Numbers: 13-000596
Study First Received: April 16, 2014
Last Updated: April 24, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Autonomic nervous system
Blood pressure
Blood vessels
Physiological effects of drugs
Vascular stiffness

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Acetylcholine
Nitroprusside
Norepinephrine
Phenylephrine
Oxymetazoline
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Nitric Oxide Donors
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on August 26, 2014