Prospective Cohort Evaluation of Cardiac Function With Echocardiography and Serum B-type Natriuretic Peptide (BNP) in Obstetrical Patients With and Without a History of Cardiac Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Assess cardiac function on echocardiography and with serum B-type natriuretic peptide for women with a history of cardiac disease and for a control group with no history of heart disease over the course of pregnancy and compare the groups
研究概览
简要总结
Maternal cardiac disease complicates approximately 2 percent of pregnancies and is the leading cause of non-obstetrical maternal death. Evaluating cardiac function and dysfunction is a complex process requiring skilled clinicians and technology such as ECG, long-term monitoring, and echocardiography. A fast, easily obtained blood test for B-type natriuretic peptide (BNP) has been developed that can give evidence for heart muscle stretch and dysfunction among adults with suspected congestive heart failure. Preliminary experience indicates that ventricular dysfunction among OB patients with a history of heart disease can be detected with this serum assay. A prospective cohort design consisting of two groups of pregnant patients; one with a history of cardiac disease and one without, will be followed over the course of the pregnancies and cardiac function will be measured using echocardiography and serum BNP. It is hoped that the blood test for BNP will be a reliable way to help evaluate OB patients with suspected abnormal heart function.
详细描述
The incidence of cardiac disease during pregnancy is about 2 percent, and is the leading cause of non-obstetrical maternal mortality (1). Women with known cardiac disease and suspected cardiac dysfunction have been monitored and evaluated during pregnancy, labor, delivery, and post partum with electrocardiogram, long-term rhythm recording, and echocardiogram (2). Physiological changes that occur in normal pregnancy include a 43% increase in cardiac output, 45 to 50% increase in intravascular volume, 14% decrease in serum colloid osmotic pressure, and 28% decrease in the colloid osmotic pressure to pulmonary capillary wedge pressure ratio. These hemodynamic changes are believed to maintain adequate uteroplacental perfusion, meet the increased oxygen and nutritional demands throughout gestation and to protect against sudden hemodynamic changes precipitated by blood loss, decreased venous return to the heart, and hypotension (3).
B-type natriuretic peptide [BNP] is released from ventricular myocardium in response to increased ventricular wall tension or stretch. A rapid assay for the measurement of serum BNP levels has been developed and is in clinical use for the evaluation of dyspnea related to ventricular dysfunction. Serum BNP determination has been described as having a higher level of diagnostic accuracy for congestive heart failure as a cause for dyspnea than any other single historical, physical, or laboratory finding. When used in conjunction with other clinical information, the rapid assay for serum BNP levels is useful in establishing or excluding cardiac dysfunction as a cause for acute onset dyspnea (4). During uncomplicated pregnancy, serum BNP levels remain the same as levels seen in non-pregnant women. Among patients with severe preeclampsia, serum BNP levels have been observed to rise to eight times baseline values. Decreased left ventricular ejection fraction and percentage of fractional shortening within myocardium was observed in the preeclampsia group compared to the normal pregnancy group. The degree of structural and functional change was linearly related to the degree of elevation of cardiac natriuretic peptides, including B-type natriuretic peptide levels (5).
Preliminary clinical experience indicates that serum BNP levels obtained by a commercially available rapid assay method may be related to the degree of ventricular dysfunction among obstetrical patients with acute dyspnea associated with preeclampsia, tocolysis therapy, or an underlying history of cardiopulmonary disease (6). The purpose of this protocol is to determine prospectively if the measurement of serum BNP levels will correlate with cardiac function changes noted on echocardiography and clinically among pregnant women with a history of cardiac disease. This group is to be compared to a group of pregnant women with no history of cardiac disease.
Specific Objectives
The specific objectives of this study include the following:
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
- 是
入选标准
- •Potential subjects for the cardiac disease in pregnancy cohort:
- •At least 18 years of age
- •Cardiac disease as per Clark's Maternal Mortality Associated with Pregnancy: Group 1 (mortality less than 1%) atrial septal defect, ventricular septal defect, patent ductus arteriosus, pulmonic or tricuspid valve disease, corrected tetrology of Fallot, bioprosthetic valve, mitral stenosis with NYHA class I and II functional status Group 2 (mortality 5-15%) mitral stenosis with NYHA class III and IV functional status, aortic stenosis, coarctation of aorta without valvular involvement, uncorrected tetrology of Fallot, previous myocardial infarction, Marfan syndrome with normal aorta, mitral stenosis with atrial fibrillation, artificial valve Group 3 (mortality 25-50%) pulmonary hypertension, coarctation of aorta with valvular involvement, Marfan syndrome with aortic involvement (7)
- •Other significant cardiac disease not listed above
- •Other medical disorders, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders, et cetera, will be acceptable
- •Diagnosis of a least a single intrauterine pregnancy, multiple gestation acceptable
- •Potential subjects for pregnancy without cardiac disease cohort:
- •At least 18 years of age
- •Absence of significant cardiac disease, minor cardiac disorders such as mitral valve prolapse without arrythmia
- •Other medical disorders, not directly related to cardiac disease, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders et cetera, will be acceptable
- •Diagnosis of at least a single intrauterine pregnancy, multiple gestation acceptable
排除标准
- •Less than 18 years of age
- •Non-viable pregnancy such as a threatened spontaneous miscarriage, or ectopic pregnancy
- •Planned termination of pregnancy, either elective or medically indicated based on history
- •Inability to complete informed consent process or participate in the study protocol
结局指标
主要结局
Assess cardiac function on echocardiography and with serum B-type natriuretic peptide for women with a history of cardiac disease and for a control group with no history of heart disease over the course of pregnancy and compare the groups
时间窗: first, second, third trimesters of a 40-week pregnancy
次要结局
- Assess for the presence of cardiac dysfunction in the course of a 40-week pregnancy(first, second, third trimesters of pregnancy)
研究者
FolkJ
Associate Professor
State University of New York - Upstate Medical University