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

Primary Purpose

Pre-Eclampsia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARTSENS Pen
Sponsored by
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pre-Eclampsia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • West Penn HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Pregnant with Pre-eclampsia

Pregnant with gestational hypertension

Pregnant without Hypertension - Control

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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
Change in Diastolic function
Measurement: E/E' velocity; This is a ratio and there is no unit for measurement. Measurement tools: Pulse Doppler echocardiography
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
Change in vascular stiffness
Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device

Secondary Outcome Measures

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.
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.

Full Information

First Posted
January 6, 2021
Last Updated
February 23, 2023
Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
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1. Study Identification

Unique Protocol Identification Number
NCT04713228
Brief Title
Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
Acronym
ARTSEN
Official Title
Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-Eclampsia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pregnant with Pre-eclampsia
Arm Type
Experimental
Arm Description
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.
Arm Title
Pregnant with gestational hypertension
Arm Type
Experimental
Arm Description
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.
Arm Title
Pregnant without Hypertension - Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ARTSENS Pen
Intervention Description
ARTerial Stiffness Evaluation for Noninvasive Screening
Primary Outcome Measure Information:
Title
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
Description
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
Time Frame
6 months
Title
Change in Diastolic function
Description
Measurement: E/E' velocity; This is a ratio and there is no unit for measurement. Measurement tools: Pulse Doppler echocardiography
Time Frame
6 months
Title
Change in vascular compliance
Description
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
Time Frame
6 months
Title
Change in vascular stiffness
Description
Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP
Description
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.
Time Frame
3 months
Title
Correlation of vascular compliance and stiffness
Description
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.
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Enrolling pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alyssa Dipaolo
Phone
412-578-4216
Email
Alyssa.Dipaolo@AHN.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Indu Poornima, MD
Organizational Affiliation
Allegheny Health Network Research Insititute
Official's Role
Principal Investigator
Facility Information:
Facility Name
West Penn Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alyssa Dipaolo
Phone
412-578-4216
Email
Alyssa.Dipaolo@AHN.ORG
First Name & Middle Initial & Last Name & Degree
Indu Poornima, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results will be published; patient identifiers will not be used in the research publications.

Learn more about this trial

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

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