Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Preeclampsia Clinical Trial

Official title:

Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01519297
• Other study ID #: PP PE 2012
• Status: Suspended
• Phase: N/A
• Start date: May 2012
• Est. completion date: July 2019

Study information

• Verified date: January 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 150
• Est. completion date: July 2019
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pregnancy-Induced
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Induced Hypertension

Intervention

Drug:
• Irbesartan
150mg orally for one dose

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular function	Assess vascular function after administration of an angiotensin receptor blocker.	60 minutes
Secondary	Hormonal measurements	Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.	60 minutes