Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Suspended

CT.gov ID

NCT01519297

Collaborator

(none)

150

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Preeclampsia Pregnancy Induced Hypertension	Drug: Irbesartan	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Actual Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Jul 1, 2017

Anticipated Study Completion Date :

Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: Single arm intervention Irbesartan 150 mg orally for one dose	Drug: Irbesartan 150mg orally for one dose

Arm

Intervention/Treatment

Other: Single arm intervention

Irbesartan 150 mg orally for one dose

Drug: Irbesartan

150mg orally for one dose

Outcome Measures

Primary Outcome Measures

Vascular function [60 minutes]
Assess vascular function after administration of an angiotensin receptor blocker.

Secondary Outcome Measures

Hormonal measurements [60 minutes]
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 50 Years

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