Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Not Applicable

Suspended

• Conditions: Pregnancy Induced Hypertension; Preeclampsia
• Interventions: Drug: Irbesartan

• Registration Number: NCT01519297
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Study Start: 2012-05
• Primary Completion: 2017-07
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm intervention	Irbesartan	Irbesartan 150 mg orally for one dose

Primary Outcome Measures

Name	Time	Method
Vascular function	60 minutes	Assess vascular function after administration of an angiotensin receptor blocker.

Secondary Outcome Measures

Name	Time	Method
Hormonal measurements	60 minutes	Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States