Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Study Description

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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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	150 participants
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

Arms and Interventions

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

Outcome Measures

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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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:	Ellen W Seely, MD	Brigham and Women's Hospital

More Information

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Responsible Party:	Ellen W. Seely, M.D., Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT01519297 History of Changes
Other Study ID Numbers:	PP PE 2012
First Posted:	January 26, 2012
Last Update Posted:	January 17, 2019
Last Verified:	January 2019

Keywords provided by Ellen W. Seely, Brigham and Women's Hospital:

Preeclampsia; Pregnancy Induced Hypertension

Additional relevant MeSH terms:

Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Vascular Diseases; Cardiovascular Diseases; Pregnancy Complications	Irbesartan; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action