Preeclampsia: A Marker for Future Cardiovascular Risk in Women

NCT ID: NCT01519297

Last Updated: 2019-01-17

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2019-07-31

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.

Conditions

Preeclampsia; Pregnancy Induced Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Single arm intervention

Irbesartan 150 mg orally for one dose

Group Type: OTHER

Irbesartan

Intervention Type: DRUG

150mg orally for one dose

Interventions

Irbesartan

150mg orally for one dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ellen W. Seely

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ellen W Seely, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

PP PE 2012

Identifier Type: -

Identifier Source: org_study_id