Preeclampsia: A Marker for Future Cardiovascular Risk in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01519297
Recruitment Status : Recruiting
First Posted : January 26, 2012
Last Update Posted : January 23, 2018
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

January 23, 2012
January 26, 2012
January 23, 2018
May 2012
June 2018   (Final data collection date for primary outcome measure)
Vascular function [ Time Frame: 60 minutes ]
Assess vascular function after administration of an angiotensin receptor blocker.
Same as current
Complete list of historical versions of study NCT01519297 on Archive Site
Hormonal measurements [ Time Frame: 60 minutes ]
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.
Same as current
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Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Preeclampsia: A Marker for Future Cardiovascular Risk in Women

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.

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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
  • Preeclampsia
  • Pregnancy Induced Hypertension
Drug: Irbesartan
150mg orally for one dose
Single arm intervention
Irbesartan 150 mg orally for one dose
Intervention: Drug: Irbesartan
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2018
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
21 Years to 50 Years   (Adult)
Contact: Ellen W Seely, MD 617-732-8538
United States
PP PE 2012
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Ellen W. Seely, Brigham and Women's Hospital
Brigham and Women's Hospital
Not Provided
Principal Investigator: Ellen W Seely, MD Brigham and Women's Hospital
Brigham and Women's Hospital
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP