PreeclampsiaNCT01519297
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
A study testing Irbesartan in people with Preeclampsia and Pregnancy Induced Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. Read more about this study
- Who is it for?
- Ages 21 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preeclampsia, Pregnancy Induced Hypertension
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jul 2019
- Phase
- Interventional
- 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 21 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
- Age 21 to 50 years
- Systolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit
- Body mass index < 35 kg/m2
- History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
- No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)
Who cannot join
- Current pregnancy
- Lactation
- Elevated blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
- Current diagnosis of hypertension
- Current diagnosis of diabetes mellitus
- Personal history of coronary disease, stroke and kidney disease
Show all 12Show fewer
- Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
- Use of oral contraceptives or other hormone therapy within 3 months of study;
- Renal impairment (estimated GFR<60)
- Active liver disease (AST, ALT, alkaline phosphatase > 1.5 times normal);
- Current smoking, defined as smoking within the 6 months before the screening visit
- Current or past recreational drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy.
This study will take place over the course of 2 weeks. Each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws.
- Conditions
- Preeclampsia, Pregnancy Induced Hypertension
- Being tested
- Irbesartan
- Keywords
- Preeclampsia, Pregnancy Induced Hypertension
- Medical subject headings
- Pre-Eclampsia, Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
150mg orally for one dose
| Study group | Role | What they receive |
|---|---|---|
| Single arm intervention | Other | Irbesartan 150 mg orally for one dose Receives: Drug: Irbesartan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular function
Assess vascular function after administration of an angiotensin receptor blocker.
Measured: 60 minutes
Secondary outcomes (1)
Hormonal measurements
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionJul 2017
- Study completionJul 2019 (estimated)
Why it stopped: Pending funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ellen W. Seely, Brigham and Women's Hospital
- Investigators
- Ellen W Seely, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01519297
- Sponsor's protocol ID
- PP PE 2012
- Status last verified
- Jan 2019
- First submitted
- 23 Jan 2012
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preeclampsia: A Marker for Future Cardiovascular Risk in Women
- ClinicalTrials.gov ID
- NCT01519297
- Acronym / sponsor ID
- PP PE 2012
- Conditions
- Preeclampsia, Pregnancy Induced Hypertension
- Keywords
- Preeclampsia, Pregnancy Induced Hypertension
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Pending funding
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2019 (estimated)
- First posted
- 26 Jan 2012 (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.
This study will compare blood vessel and hormone differences between women who have a history of a pregnancy complicated by preeclampsia or high blood pressure, and women who have a history of uncomplicated pregnancy in the last 10 years. The investigators hypothesize that postpartum women with history of preeclampsia will have altered blood vessel function and abnormal hormone levels compared with postpartum women with history of uncomplicated pregnancy.
This study will take place over the course of 2 weeks. Each subject will be assessed on a fixed low-salt diet and a fixed high-salt diet. Subjects will have 2 non-invasive blood vessel imaging tests and fasting blood draws.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm intervention | Other | Drug: IrbesartanIrbesartan 150 mg orally for one dose |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
- Age 21 to 50 years
- Systolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit
- Body mass index < 35 kg/m2
- History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
Key exclusion criteria (12 listed)
- Current pregnancy
- Lactation
- Elevated blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
- Current diagnosis of hypertension
- Current diagnosis of diabetes mellitus
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 |
|---|---|---|
| Irbesartan150mg orally for one dose | Drug | Single arm intervention |
Primary outcome
Vascular function
Time frame: 60 minutes
Assess vascular function after administration of an angiotensin receptor blocker.
1 secondary outcome
Hormonal measurements
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
Related trials for Preeclampsia
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The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
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Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
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.
Ellen W Seely, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Irbesartan in people with Preeclampsia and Pregnancy Induced Hypertension, run by Brigham and Women's Hospital 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 6 inclusion and 12 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: paused, as of the sponsor's last update on 17 Jan 2019. 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?
Results are not available in the source record.
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?
Vascular function (time frame: 60 minutes). 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 17 Jan 2019.