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

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.

Study Overview

• Status: Terminated
• Conditions: Pre-Eclampsia
• Intervention / Treatment: Device: ARTSENS Pen

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alyssa Dipaolo; Phone Number: 412-578-4216; Email: Alyssa.Dipaolo@AHN.ORG

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Exclusion Criteria:

1. Prior history and/or current diagnosis 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pregnant with Pre-eclampsia; 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; ARTerial Stiffness Evaluation for Noninvasive Screening
Experimental: Pregnant with gestational hypertension; 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; ARTerial Stiffness Evaluation for Noninvasive Screening
Active Comparator: Pregnant without Hypertension - Control; 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; ARTerial Stiffness Evaluation for Noninvasive Screening

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Investigators: Principal Investigator: Indu Poornima, MD, Allegheny Health Network Research Insititute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): January 17, 2024
• Study Completion (Actual): January 17, 2024

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: 2019-128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published; patient identifiers will not be used in the research publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No