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

NCT ID: NCT04713228

Last Updated: 2024-01-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2024-01-17

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.

Conditions

Pre-Eclampsia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

ARTSENS Pen

Intervention Type: DEVICE

ARTerial Stiffness Evaluation for Noninvasive Screening

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.

Group Type: EXPERIMENTAL

ARTSENS Pen

Intervention Type: DEVICE

ARTerial Stiffness Evaluation for Noninvasive Screening

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.

Group Type: ACTIVE_COMPARATOR

ARTSENS Pen

Intervention Type: DEVICE

ARTerial Stiffness Evaluation for Noninvasive Screening

Interventions

ARTSENS Pen

ARTerial Stiffness Evaluation for Noninvasive Screening

Intervention Type: DEVICE

Eligibility Criteria

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.

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.

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

OTHER

Sponsor Role: lead

Responsible Party

Indu Poornima

Director, Section of Cardiovascular Prevention, AHN; Professor of Medicine, Drexel University College of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Indu Poornima, MD

Role: PRINCIPAL_INVESTIGATOR

Allegheny Health Network Research Insititute

Locations

West Penn Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

2019-128

Identifier Type: -

Identifier Source: org_study_id