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

Not Applicable

Terminated

• Conditions: Pre-Eclampsia
• Interventions: Device: ARTSENS Pen

• Registration Number: NCT04713228
• Lead Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

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.

Study Timeline

• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-19
• Study Start: 2021-07-01
• Status Verified: 2024-01
• Primary Completion: 2024-01-17
• Study Completion: 2024-01-17
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregnant with Pre-eclampsia	ARTSENS Pen	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	ARTSENS Pen	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	ARTSENS Pen	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.

Primary Outcome Measures

Name	Time	Method
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)	6 months	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	6 months	Measurement: E/E' velocity; This is a ratio and there is no unit for measurement.; Measurement tools: Pulse Doppler echocardiography
Change in vascular compliance	6 months	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	6 months	Measurement: Beta which is an index without units; Measurement tool: Arterial waveforms captured with the ARTSENS device

Secondary Outcome Measures

Name	Time	Method
Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP	3 months	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	3 months	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.

Trial Locations

Locations (1)

West Penn Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States