NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Postpartum cardiac complications
研究概览
简要总结
The purpose of this study is to determine if NT-BNP levels obtained at time of admission for delivery are predictive of intrapartum or postpartum complications in patients with adult congenital heart disease.
详细描述
Amino-terminal pro-B-type natiuretic peptide (NT-proBNP) is a prohormone released from cardiac ventricular myocytes in direct response to cardiac workload. Secreted in the biologically inactive form, NT-proBNP is cleaved in the circulation into BNP, which subsequently exerts both vasodilatory and diuretic effects. The principal clinical utility of serum NT-proBNP measurement has been as an adjunctive marker in the diagnosis of subclinical heart failure, with higher levels typically reflective of increasing cardiac dysfunction.
The proposed prospective cohort study intends to collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events. Both pregnant patients with previously-diagnosed ACHD and those diagnosed and delivering during the study interval will be candidates for participation, and a gestational age threshold of 37 weeks will be utilized for the control group.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant adult women ages 18 - 50
- •Pregnancy with congenital heart disease (study group) or without congenital heart disease (control group)
排除标准
- •Non-pregnant patients
- •Non-English-speaking patients
- •Maternal age <18 years or >50 years
- •Patients with hypertensive complications of pregnancy
- •Maternal peripartum cardiomyopathy
- •Multiple gestation
结局指标
主要结局
Postpartum cardiac complications
时间窗: Initial 96 hours following delivery of infant(s)
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
Intrapartum cardiac complications
时间窗: Inpatient admission for subsequent 48 hours
Incidence of heart failure, incidence of arrhythmia, incidence of cardiac arrest
次要结局
- Intrapartum obstetrical complications(Inpatient admission for subsequent 48 hours)
- Postpartum obstetrical complications(Initial 96 hours following delivery of infant(s))