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Preeclampsia: A Marker for Future Cardiovascular Risk in Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Brigham and Women's Hospital
Sponsor:
Information provided by (Responsible Party):
Ellen W. Seely, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01519297
First received: January 23, 2012
Last updated: September 19, 2014
Last verified: September 2014

January 23, 2012
September 19, 2014
May 2012
May 2015   (final data collection date for primary outcome measure)
Vascular function [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Assess vascular function after administration of an angiotensin receptor blocker.
Same as current
Complete list of historical versions of study NCT01519297 on ClinicalTrials.gov Archive Site
Hormonal measurements [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
May 2015
May 2015   (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 45 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
Female
21 Years to 45 Years
Yes
Contact: Ellen W Seely, MD 617-732-8538
United States
 
NCT01519297
PP PE 2012
Yes
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
September 2014

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