Clinical trial NCT04713228: Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
Official title: Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
timeFrame: 6 months
measure: Change in Diastolic function
timeFrame: 6 months
measure: Change in vascular compliance
timeFrame: 6 months
measure: Change in vascular stiffness
timeFrame: 6 months
Secondary outcomes:
measure: Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP
timeFrame: 3 months
measure: Correlation of vascular compliance and stiffness
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: West Penn Hospital
state: Pennsylvania
Study officials:
affiliation: Allegheny Health Network Research Insititute
name: Indu Poornima, MD
role: PRINCIPAL_INVESTIGATOR
References: