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

NCT04713228 | Terminated DMC FDA Device

• 1 other identifier: 2019-128
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-Eclampsia

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP

  3 months

• Correlation of vascular compliance and stiffness

  3 months

Study Arms (3)

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.

Device: ARTSENS Pen

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.

Device: ARTSENS Pen

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.

Device: ARTSENS Pen

Interventions

ARTSENS Pen DEVICE

ARTerial Stiffness Evaluation for Noninvasive Screening

Pregnant with Pre-eclampsia; Pregnant with gestational hypertension; Pregnant without Hypertension - Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Enrolling pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Indu Poornima, MD

  Allegheny Health Network Research Insititute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Section of Cardiovascular Prevention, AHN; Professor of Medicine, Drexel University College of Medicine

Study Record Dates

• First Submitted: January 6, 2021
• First Posted: January 19, 2021
• Study Start: July 1, 2021
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)