Preeclampsia: A Marker for Future Cardiovascular Risk in Women
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ClinicalTrials.gov Identifier: NCT01519297 |
Recruitment Status
:
Recruiting
First Posted
: January 26, 2012
Last Update Posted
: January 23, 2018
|
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Preeclampsia Pregnancy Induced Hypertension | Drug: Irbesartan | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Screening |
Official Title: | Preeclampsia: A Marker for Future Cardiovascular Risk in Women |
Study Start Date : | May 2012 |
Estimated Primary Completion Date : | June 2018 |
Estimated Study Completion Date : | June 2018 |

Arm | Intervention/treatment |
---|---|
Single arm intervention
Irbesartan 150 mg orally for one dose
|
Drug: Irbesartan
150mg orally for one dose
|
- Vascular function [ Time Frame: 60 minutes ]Assess vascular function after administration of an angiotensin receptor blocker.
- Hormonal measurements [ Time Frame: 60 minutes ]Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.

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Ages Eligible for Study: | 21 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519297
Contact: Ellen W Seely, MD | 617-732-8538 |
United States, Massachusetts | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Ellen W Seely, MD | Brigham and Women's Hospital |
Responsible Party: | Ellen W. Seely, M.D., Brigham and Women's Hospital |
ClinicalTrials.gov Identifier: | NCT01519297 History of Changes |
Other Study ID Numbers: |
PP PE 2012 |
First Posted: | January 26, 2012 Key Record Dates |
Last Update Posted: | January 23, 2018 |
Last Verified: | January 2018 |
Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Preeclampsia Pregnancy Induced Hypertension |
Additional relevant MeSH terms:
Hypertension, Pregnancy-Induced Hypertension Pre-Eclampsia Vascular Diseases Cardiovascular Diseases Pregnancy Complications |
Irbesartan Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists Molecular Mechanisms of Pharmacological Action |