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.

Study Overview

• Status: Suspended
• Conditions: Preeclampsia; Pregnancy Induced Hypertension
• Intervention / Treatment: Drug: Irbesartan

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm intervention; Irbesartan 150 mg orally for one dose	Drug: Irbesartan; 150mg orally for one dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular function	Assess vascular function after administration of an angiotensin receptor blocker.	60 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2012
• Primary Completion (Actual): July 1, 2017
• Study Completion (Anticipated): July 1, 2019

Study Registration Dates

• First Submitted: January 23, 2012
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (Estimate): January 26, 2012

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Preeclampsia; Pregnancy Induced Hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Irbesartan
• Other Study ID Numbers: PP PE 2012