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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregnant with Pre-eclampsia | Experimental | 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. |
|
| Pregnant with gestational hypertension | Experimental | 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. |
|
| Pregnant without Hypertension - Control | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARTSENS Pen | Device | ARTerial Stiffness Evaluation for Noninvasive Screening |
|
| 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 |
| 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 |
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Case Inclusion Criteria:
Case Exclusion Criteria:
Control Inclusion Criteria:
Control Exclusion Criteria:
Enrolling pregnant women
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| Name | Affiliation | Role |
|---|---|---|
| Indu Poornima, MD | Allegheny Health Network Research Insititute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Penn Hospital | Pittsburgh | Pennsylvania | 15224 | United States |
Results will be published; patient identifiers will not be used in the research publications.
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 25, 2024 | Dec 16, 2024 | 7 | ||
| Jan 2, 2025 |
| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| Jan 27, 2025 |
| 8 |
| May 20, 2025 | Jun 5, 2025 | 9 |
| Feb 4, 2026 | Feb 20, 2026 | 10 |