NCT04713228

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DEVICE	ARTSENS Pen	ARTerial Stiffness Evaluation for Noninvasive Screening

Timeline

• Start date: 2021-07-01
• Primary completion: 2024-01-17
• Completion: 2024-01-17
• First posted: 2021-01-19
• Last updated: 2024-01-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study