LeiomyomaNCT02123069
Vascular Function and Uterine Fibroids
An observational study of Leiomyoma, run by Mayo Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Leiomyoma
- What is being tested?
- Brachial artery catheter, Acetylcholine and Nitroprusside
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Women 25-50 years old
- Premenopausal
Who cannot join
- 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
Show all 10Show fewer
- Chronic diseases (for example: Crohn's disease, rheumatoid arthritis, bipolar mood disorder, etc.)
- Smoker
- High cholesterol
- BMI higher than 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata
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.
Read the 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.
- Conditions
- Leiomyoma
- Being tested
- Brachial artery catheter, Acetylcholine, Nitroprusside, Norepinephrine, Nitroprusside and phenylephrine
- Keywords
- Autonomic nervous system, Blood pressure, Blood vessels, Physiological effects of drugs, Vascular stiffness
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial artery catheterDevice
A catheter will be placed in the brachial artery by a physician on the study day.
AcetylcholineDrug
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.
NitroprussideDrug
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.
NorepinephrineDrug
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 phenylephrineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Women with uterine fibroids | * Brachial artery catheter
* Acetylcholine
* Nitroprusside
* Norepinephrine
* Nitroprusside and phenylephrine Receives: 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 Receives: Device: Brachial artery catheter; Drug: Acetylcholine; Drug: Nitroprusside; Drug: Norepinephrine; Drug: Nitroprusside and phenylephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline systolic, diastolic, and mean blood pressures
Measured: One day (study day)
Baseline sympathetic nerve activity
Nerve "burst" activity will be measured across 10 minutes.
Measured: One day (study day)
Secondary outcomes (5)
Changes in forearm blood flow levels in response to acetylcholine infusion
Measured: One day (study day)
Changes in forearm blood flow levels in response to nitroprusside infusion
Measured: One day (study day)
Changes in forearm blood flow levels in response to norepinephrine infusion
Measured: One day (study day)
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.
Measured: One day (study)
Pulse wave velocity (an index of vessel stiffness)
Measured: One day (study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startApr 2013
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael J. Joyner, M.D., Mayo Clinic
- Investigators
- Michael J Joyner, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123069
- Sponsor's protocol ID
- 13-000596
- Status last verified
- Mar 2018
- First submitted
- 16 Apr 2014
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sympathetic Nerve Activity and Vascular Function in Women With Uterine Leiomyomata
- ClinicalTrials.gov ID
- NCT02123069
- Acronym / sponsor ID
- 13-000596
- Conditions
- Leiomyoma
- Keywords
- Autonomic nervous system, Blood pressure, Blood vessels, Physiological effects of drugs, Vascular stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with uterine fibroids | – | Device: Brachial artery catheter, Drug: Acetylcholine, Drug: Nitroprusside, Drug: Norepinephrine, Drug: Nitroprusside and phenylephrine* Brachial artery catheter * Acetylcholine * Nitroprusside * Norepinephrine * Nitroprusside and phenylephrine |
| Women without uterine fibroids | – | Device: Brachial artery catheter, Drug: Acetylcholine, Drug: Nitroprusside, Drug: Norepinephrine, Drug: Nitroprusside and phenylephrine* Brachial artery catheter * Acetylcholine * Nitroprusside * Norepinephrine * Nitroprusside and phenylephrine |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Women 25-50 years old
- Premenopausal
Key exclusion criteria (10 listed)
- Postmenopausal
- Pregnant or currently breastfeeding
- Using blood pressure medications or anti-depression medications
- High blood pressure
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachial artery catheterA catheter will be placed in the brachial artery by a physician on the study day. | Device | Women with uterine fibroids, Women without uterine fibroids |
| AcetylcholineAcetylcholine 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 | Women with uterine fibroids, Women without uterine fibroids |
| NitroprussideNitroprusside 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 | Women with uterine fibroids, Women without uterine fibroids |
| NorepinephrineNorepinephrine 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 | Women with uterine fibroids, Women without uterine fibroids |
| Nitroprusside and phenylephrineA 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. | Drug | Women with uterine fibroids, Women without uterine fibroids |
Primary outcome
Baseline systolic, diastolic, and mean blood pressures
Time frame: One day (study day)
Baseline sympathetic nerve activity
Time frame: One day (study day)
Nerve "burst" activity will be measured across 10 minutes.
5 secondary outcomes
Changes in forearm blood flow levels in response to acetylcholine infusion
Time frame: One day (study day)
Changes in forearm blood flow levels in response to nitroprusside infusion
Time frame: One day (study day)
Changes in forearm blood flow levels in response to norepinephrine infusion
Time frame: One day (study day)
Change in blood pressure in response to infusions of nitroprusside and phenylephrine
Time frame: One day (study)
Pulse wave velocity (an index of vessel stiffness)
Time frame: One day (study day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
Related trials for Leiomyoma
RecruitingObservational study
Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
Uterine Fibroids, Hysterectomy
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingObservational study
The Effects of Uterine Fibroids on Pregnancy in Women
Female Infertility, Uterine Fibroid
RecruitingObservational study
Epidemiology and Risk Factors of Uterine Fibroids in China
Uterine Fibroid
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Joyner, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leiomyoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline systolic, diastolic, and mean blood pressures (time frame: One day (study day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.