Pre-Eclampsia
Conditions
Brief summary
This is a research study to understand the changes in the heart and the cardiovascular system that may occur in women who develop high blood pressure during pregnancy.
Detailed description
Upon Enrollment in this study, participants will go through two scans along with some blood test and other assessments. The first scan is a sonogram of the heart called an echocardiogram, and another scan is done using the investigational ARTSENS device that will be used to measure stiffness of the walls in the arterial blood vessel for indications of inflammation damage. ARTSENS device is not approved for use in the United States. It is expected that we will enroll 50 people in this study. The entire study is expected to last 2 years. Participation will be for approximately 9 months.
Interventions
DEVICEARTSENS Pen
ARTerial Stiffness Evaluation for Noninvasive Screening
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Case Inclusion Criteria: 1. Adult females age \> 18 years 2. Must be able to read and understand English and consent for themselves 3. Must have a singleton pregnancy and a diagnosis of preeclampsia or gestational hypertension 4. Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks and then at 6-7 months. Case
Exclusion criteria
1. Prior history of hypertension 2. Multiple pregnancies 3. Other comorbidities such as congenital heart disease, dialysis dependent renal failure, heroin abuse, cocaine abuse, pulmonary hypertension, congestive heart failure, autoimmune conditions such as SLE or severe lung disease. 4. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Control Inclusion Criteria: 1. Adult females age \> 18 years 2. Must be able to read and understand English and consent for themselves 3. Must have a singleton pregnancy and not have a prior or current diagnosis of hypertension 4. Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks. Control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic Function measured as Left ventricular ejection fraction (LVEF) | 6 months | Measurement: LVEF is expressed as a % and Global longitudinal strain measurement also expressed as %. Measurements tools: two dimensional echocardiography and strain imaging with speckle tracking echocardiography |
| Change in Diastolic function | 6 months | Measurement: E/E' velocity; This is a ratio and there is no unit for measurement. Measurement tools: Pulse Doppler echocardiography |
| Change in vascular compliance | 6 months | Measurement: Pulse strain elasticity (Ep) expressed as kPa, Arterial stiffness Beta which is an index without units. Measurement tool: Arterial waveforms captured with the ARTSENS device |
| Change in vascular stiffness | 6 months | Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP | 3 months | Cardiac measurements: LVEF is in %, Troponin is ng/ml, proBNP is pmol/L Measurement tool: LVEF is measured with 2D echocardiography, proBNP and Troponin is measured by blood sample assessing biomarker alterations that could predict cardiovascular damage. |
| Correlation of vascular compliance and stiffness | 3 months | Measurement: Pulse strain elasticity (Ep) expressed as kPa, Arterial stiffness Beta which is an index without units, E/E' is a ratio Measurement tool: Arterial waveforms captured with the ARTSENS device and Doppler Echo. |
Countries
United States
Outcome results
None listed