Preeclampsia: A Marker for Future Cardiovascular Risk in Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 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: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Preeclampsia
Pregnancy Induced Hypertension
Drug: Irbesartan

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Preeclampsia: A Marker for Future Cardiovascular Risk in Women

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Vascular function [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Assess vascular function after administration of an angiotensin receptor blocker.


Secondary Outcome Measures:
  • Hormonal measurements [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]
    Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.


Estimated Enrollment: 150
Study Start Date: May 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single arm intervention
Irbesartan 150 mg orally for one dose
Drug: Irbesartan
150mg orally for one dose

  Eligibility

Ages Eligible for Study:   21 Years to 45 Years
Genders 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 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519297

Contacts
Contact: Ellen W Seely, MD 617-732-8538

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
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

No publications provided

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
Study First Received: January 23, 2012
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Preeclampsia
Pregnancy Induced Hypertension

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
Vascular Diseases
Cardiovascular Diseases
Pregnancy Complications
Irbesartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014