Preeclampsia: A Marker for Future Cardiovascular Risk in Women

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01519297
• Date of registration: 23/01/2012
• Prospective Registration: Yes
• Primary sponsor: Brigham and Women's Hospital
• Public title: Preeclampsia: A Marker for Future Cardiovascular Risk in Women
• Scientific title: Preeclampsia: A Marker for Future Cardiovascular Risk in Women
• Date of first enrolment: May 2012
• Target sample size: 150
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT01519297
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Screening. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Ellen W Seely, MD
• Affiliation: Brigham and Women's Hospital

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Preeclampsia

Pregnancy Induced Hypertension

Intervention(s)

Drug: Irbesartan

Primary Outcome(s)

Vascular function [Time Frame: 60 minutes]

Secondary Outcome(s)

Hormonal measurements [Time Frame: 60 minutes]

Secondary ID(s)

PP PE 2012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors