Back to resultsPreeclampsia: A Marker for Future Cardiovascular Risk in Women
Primary Purpose
Preeclampsia, Pregnancy Induced Hypertension
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Irbesartan
Sponsored by
About this trial
This is an interventional screening trial for Preeclampsia focused on measuring Preeclampsia, Pregnancy Induced Hypertension
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm intervention
Arm Description
Irbesartan 150 mg orally for one dose
Outcomes
Primary Outcome Measures
Vascular function
Assess vascular function after administration of an angiotensin receptor blocker.
Secondary Outcome Measures
Hormonal measurements
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.
Full Information
NCT ID
NCT01519297
First Posted
January 23, 2012
Last Updated
January 15, 2019
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01519297
Brief Title
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Official Title
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Suspended
Why Stopped
Pending funding
Study Start Date
May 2012 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia, Pregnancy Induced Hypertension
Keywords
Preeclampsia, Pregnancy Induced Hypertension
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single arm intervention
Arm Type
Other
Arm Description
Irbesartan 150 mg orally for one dose
Intervention Type
Drug
Intervention Name(s)
Irbesartan
Intervention Description
150mg orally for one dose
Primary Outcome Measure Information:
Title
Vascular function
Description
Assess vascular function after administration of an angiotensin receptor blocker.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Hormonal measurements
Description
Assess hormone levels pertaining to the renin-angiotensin system after administration of irbesartan.
Time Frame
60 minutes
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen W Seely, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Preeclampsia: A Marker for Future Cardiovascular Risk in Women
We'll reach out to this number within 24 hrs