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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. Read our disclaimer for details. Identifier: NCT01519297
Recruitment Status : Suspended (Pending funding)
First Posted : January 26, 2012
Last Update Posted : January 17, 2019
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Preeclampsia Pregnancy Induced Hypertension Drug: Irbesartan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Actual Study Start Date : May 2012
Actual Primary Completion Date : July 2017
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Irbesartan

Arm Intervention/treatment
Single arm intervention
Irbesartan 150 mg orally for one dose
Drug: Irbesartan
150mg orally for one dose

Primary Outcome Measures :
  1. Vascular function [ Time Frame: 60 minutes ]
    Assess vascular function after administration of an angiotensin receptor blocker.

Secondary Outcome Measures :
  1. Hormonal measurements [ Time Frame: 60 minutes ]
    Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01519297

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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Ellen W Seely, MD Brigham and Women's Hospital
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Responsible Party: Ellen W. Seely, M.D., Brigham and Women's Hospital Identifier: NCT01519297    
Other Study ID Numbers: PP PE 2012
First Posted: January 26, 2012    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:
Pregnancy Induced Hypertension
Additional relevant MeSH terms:
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Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action