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Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Status
Suspended
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01519297
Enrollment
150
Registered
2012-01-26
Start date
2012-05-31
Completion date
2019-07-31
Last updated
2019-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia, Pregnancy Induced Hypertension

Keywords

Preeclampsia, Pregnancy Induced Hypertension

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.

Interventions

DRUGIrbesartan

150mg orally for one dose

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Vascular function60 minutesAssess vascular function after administration of an angiotensin receptor blocker.

Secondary

MeasureTime frameDescription
Hormonal measurements60 minutesAssess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026