Prospective Case-Control Study of Cardiovascular Changes in Pregnancy Related Hypertensive Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Case Inclusion Criteria:
- •Adult females age > 18 years
- •Must be able to read and understand English and consent for themselves
- •Must have a singleton pregnancy and a diagnosis of preeclampsia or gestational hypertension
- •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.
排除标准
- •Prior history of hypertension
- •Multiple pregnancies
- •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.
- •Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- •Control Inclusion Criteria:
- •Adult females age > 18 years
- •Must be able to read and understand English and consent for themselves
- •Must have a singleton pregnancy and not have a prior or current diagnosis of hypertension
- •Must be willing and able to come to West Penn Hospital for post-partum visits at 6-8 weeks.
- •Control Exclusion Criteria:
- •Prior history and/or current diagnosis of hypertension
- •Multiple pregnancies
- •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.
- •Subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
结局指标
主要结局
Change in Systolic Function measured as Left ventricular ejection fraction (LVEF)
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 6 months
Measurement: Beta which is an index without units Measurement tool: Arterial waveforms captured with the ARTSENS device
次要结局
- Correlation of left ventricular ejection fraction (LVEF) with troponin and proBNP(3 months)
- Correlation of vascular compliance and stiffness(3 months)
研究者
Indu Poornima
Director, Section of Cardiovascular Prevention, AHN; Professor of Medicine, Drexel University College of Medicine
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)