Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Mass General Brigham

Status: Suspended

Conditions: Pregnancy Induced Hypertension; Preeclampsia

Treatments: Drug: Irbesartan

Study type: Interventional

Funder types: Other

Identifiers

NCT01519297

PP PE 2012

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
2. Age 21 to 50 years
3. Systolic blood pressure <140 and >90 mmHg and diastolic blood pressure <90 and >60 mmHg at the screening visit
4. Body mass index < 35 kg/m2
5. History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)

Exclusion criteria

1. Current pregnancy
2. Lactation
3. Elevated blood pressure (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
4. Current diagnosis of hypertension
5. Current diagnosis of diabetes mellitus
6. Personal history of coronary disease, stroke and kidney disease
7. Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
8. Use of oral contraceptives or other hormone therapy within 3 months of study;
9. Renal impairment (estimated GFR<60)
10. Active liver disease (AST, ALT, alkaline phosphatase > 1.5 times normal);
11. Current smoking, defined as smoking within the 6 months before the screening visit
12. Current or past recreational drug use

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Single arm intervention

Other group

Description:

Irbesartan 150 mg orally for one dose

Treatment:

Drug: Irbesartan