Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders

Conditions
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Pre-Eclampsia

Intervention / Treatment
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* Device: ARTSENS Pen


Participation Criteria
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Eligibility Criteria
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Case Inclusion Criteria: Adult females age > 18 years Must be able to read and understand English and consent for themselves Must have a singleton pregnancy and a diagnosis of preeclampsia or gestational hypertension 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: Prior history of hypertension Multiple pregnancies 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. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Control Inclusion Criteria: Adult females age > 18 years Must be able to read and understand English and consent for themselves Must have a singleton pregnancy and not have a prior or current diagnosis of hypertension Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks. Control Exclusion Criteria: Prior history and/or current diagnosis of hypertension Multiple pregnancies 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. Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregnant with Pre-eclampsia<br>There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. | Device: ARTSENS Pen<br>* ARTerial Stiffness Evaluation for Noninvasive Screening<br>|
| Experimental: Pregnant with gestational hypertension<br>There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit will be 6-7 months post partum where there is a collection of a clinical questionnaire, demographics, vitals, chart review, echocardiogram and vascular compliance will be re-measured. | Device: ARTSENS Pen<br>* ARTerial Stiffness Evaluation for Noninvasive Screening<br>|
| Active Comparator: Pregnant without Hypertension - Control<br>There will be an initial 'Pregnancy' visit within 7-10 days of the screening visit, when the subject will undergo an echocardiogram, have the vascular compliance measurements and will have blood drawn for measurement of serum biomarkers. The second study visit will be the '6-8 weeks post-partum' visit when the echocardiogram and vascular compliance will be re-measured, along with assessment of vitals and medication history. The third study visit is not applicable to the control group. | Device: ARTSENS Pen<br>* ARTerial Stiffness Evaluation for Noninvasive Screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Systolic Function measured as Left ventricular ejection fraction (LVEF) | 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 | 6 months | 
| Change in Diastolic function | Measurement: E/E' velocity; This is a ratio and there is no unit for measurement. Measurement tools: Pulse Doppler echocardiography | 6 months | 
| Change in vascular compliance | 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 | 6 months | 
| Change in vascular stiffness | Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP | 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. | 3 months | 
| Correlation of vascular compliance and stiffness | 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. | 3 months |