Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Screening
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2017

Interventions

  • Drug: Irbesartan
    • 150mg orally for one dose

Arms, Groups and Cohorts

  • Other: Single arm intervention
    • Irbesartan 150 mg orally for one dose

Clinical Trial Outcome Measures

Primary Measures

  • Vascular function
    • Time Frame: 60 minutes
    • Assess vascular function after administration of an angiotensin receptor blocker.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 21 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brigham and Women’s Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ellen W. Seely, M.D. – Brigham and Women’s Hospital
  • Overall Official(s)
    • Ellen W Seely, MD, Principal Investigator, Brigham and Women’s Hospital

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