Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Study Overview
=================
Brief 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. 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.

Official Title
-----------------
Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Conditions
-----------------
Preeclampsia, Pregnancy Induced Hypertension

Intervention / Treatment
-----------------
* Drug: Irbesartan


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single arm intervention<br>Irbesartan 150 mg orally for one dose | Drug: Irbesartan<br>* 150mg orally for one dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Assess vascular function after administration of an angiotensin receptor blocker. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal measurements | Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan. | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Preeclampsia, Pregnancy Induced Hypertension