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

Pre-Eclampsia Clinical Trial

— ARTSEN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04713228
• Other study ID #: 2019-128
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: January 17, 2024

Study information

• Verified date: January 2024
• Source: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eclampsia
• Hypertension
• Pre-Eclampsia

Intervention

Device:
• ARTSENS Pen
ARTerial Stiffness Evaluation for Noninvasive Screening

Locations

Country	Name	City	State
United States	West Penn Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Change in vascular stiffness	Measurement: Beta which is an index without units; Measurement tool: Arterial waveforms captured with the ARTSENS device	6 months
Secondary	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
Secondary	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