NCT01519297

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

5.2 years

First QC Date

January 23, 2012

Last Update Submit

January 15, 2019

Conditions

PreeclampsiaPregnancy Induced Hypertension

Keywords

PreeclampsiaPregnancy Induced Hypertension

Outcome Measures

Primary Outcomes (1)

  • Vascular function

    Assess vascular function after administration of an angiotensin receptor blocker.

    60 minutes

Secondary Outcomes (1)

  • Hormonal measurements

    60 minutes

Study Arms (1)

Single arm intervention

OTHER

Irbesartan 150 mg orally for one dose

Drug: Irbesartan

Interventions

IrbesartanDRUG

150mg orally for one dose

Single arm intervention

Eligibility Criteria

Age21 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy female premenopausal volunteers, with regular menstrual cycles (at least 8 cycles per year)
  • Age 21 to 50 years
  • Systolic blood pressure \<140 and \>90 mmHg and diastolic blood pressure \<90 and \>60 mmHg at the screening visit
  • Body mass index \< 35 kg/m2
  • History of normotensive pregnancy or history of preeclamptic or hypertensive pregnancy within the last 10 years
  • No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis, and electrocardiogram)

You may not qualify if:

  • Current pregnancy
  • Lactation
  • Elevated blood pressure (systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg)
  • Current diagnosis of hypertension
  • Current diagnosis of diabetes mellitus
  • Personal history of coronary disease, stroke and kidney disease
  • Use of prescription medications (with the exception of stable thyroid hormone replacement dose) within 2 weeks of study
  • Use of oral contraceptives or other hormone therapy within 3 months of study;
  • Renal impairment (estimated GFR\<60)
  • Active liver disease (AST, ALT, alkaline phosphatase \> 1.5 times normal);
  • Current smoking, defined as smoking within the 6 months before the screening visit
  • Current or past recreational drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pre-EclampsiaHypertension, Pregnancy-Induced

Interventions

Irbesartan

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsSpiro CompoundsTetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic Compounds

Study Officials

  • Ellen W Seely, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

January 23, 2012

First Posted

January 26, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2017

Study Completion

July 1, 2019

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations

US(1)