Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease
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|ClinicalTrials.gov Identifier: NCT00759733|
Recruitment Status : Unknown
Verified August 2010 by State University of New York - Upstate Medical University.
Recruitment status was: Not yet recruiting
First Posted : September 25, 2008
Last Update Posted : August 5, 2010
|First Submitted Date||September 24, 2008|
|First Posted Date||September 25, 2008|
|Last Update Posted Date||August 5, 2010|
|Study Start Date||July 2008|
|Estimated Primary Completion Date||July 2011 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures
||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 [ Time Frame: first, second, third trimesters of a 40-week pregnancy ]|
|Original Primary Outcome Measures||Same as current|
|Change History||Complete list of historical versions of study NCT00759733 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||Assess for the presence of cardiac dysfunction in the course of a 40-week pregnancy [ Time Frame: first, second, third trimesters of pregnancy ]|
|Original Secondary Outcome Measures||Same as current|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease|
|Official Title||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|
|Brief Summary||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.|
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.
The specific objectives of this study include the following:
This study protocol employs a prospective cohort design. A group of woman with a history of cardiac disease and pregnancy will be identified as potential subjects for a study cohort. Each potential subject will have an initial assessment of her cardiac history, condition, and functional status. A detailed review of her complete medical, surgical, gynecologic, and obstetrical history will be obtained as dictated by standard care. Appropriate management for each potential subject's medical and obstetrical care will be initiated and undertaken by accepted clinical practice. Potential subjects for this cohort will be obstetrical patients either cared for directly by or in consultation with the Regional Perinatal Center, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, SUNY Upstate Medical University.
A second group of women with no history of cardiac disease and pregnancy will also be identified as potential subjects for a control cohort. Each potential subject will also have an initial assessment of her medical, surgical, gynecologic, and obstetrical history as dictated by standard care. Appropriate management for each potential subject's medical and obstetrical care will be initiated and undertaken by accepted clinical practice. Potential subjects for this cohort will be obstetrical patients either cared for directly by or in consultation with the Regional Perinatal Center, Division of Maternal Fetal Medicine, Department of Obstetrics & Gynecology, SUNY Upstate Medical University.
In addition to the management given as part of standard medical and obstetrical care, each subject from both cohorts will have a series of serum BNP measurements and echocardiograms. A serum BNP measurement and echocardiogram will be obtained during the first, second, and third trimesters, during the course of labor or delivery, 48 to 72 hours post-delivery, and 6 to 8 weeks post-delivery. Additional studies will be obtained as indicated by standard clinical indications. Serum BNP measurements will be made through laboratory services available at SUNY Upstate Medical University or Crouse Hospital. Echocardiogram studies will be performed at Cardiology P.C. or Pediatric Cardiology at SUNY Upstate Medical University.
A standard form will be used for each subject to record the results of the serum BNP measurements, results of the maternal echocardiograms, and details of the clinical course experienced by each subject during the course of her pregnancy, labor, delivery, and post-delivery care. Complications related to cardiac function as well as other medical and obstetrical complications will also be recorded. Please see the attached standard data collection form for details.
At the conclusion of the study, a comparison will be made between the cohort of women with cardiac disease and the cohort of woman without cardiac disease. Specific comparison will be made in regard to serum BNP levels, cardiac function as measured on echocardiography, and clinical course.
Statistical Methods, Data Analysis, Interpretation
There are no prior published reports regarding the use of a rapid serum BNP assay to evaluate cardiac function during pregnancy for women with known cardiac disease. From June 1, 2003 to May 31, 2004, the Regional Perinatal Center at SUNY Upstate Medical University provided obstetrical care and consultation for 55 patients with ICD-9 Code 648.63, cardiac disease in pregnancy. Since this is a pilot study, it is anticipated that 20 subjects for the cardiac disease cohort can be followed over the course of 1 to 2 years, along with a control cohort.
Specific measurements that will be obtained by echocardiography and recorded as measures of cardiac function will include:
Serum BNP measurements will be obtained and recorded as units of picograms/milliliter. Approximately 3-4 milliliters of blood is obtained per assay in a standard lavender-top tube by standard blood sampling methods. The rapid quantitative assay for BNP will be run on the Triage® BNP Test (International) of Biosite Diagnostics, Incorporated, San Diego, California.
Measurements of serum BNP will be correlated with clinical course and objective measures of cardiac function as determined by echocardiography. A linear relationship between the elevation of serum BNP measurement and degree of cardiac dysfunction is expected. Elevated serum BNP and cardiac dysfunction demonstrated on echocardiogram should also correlate with the clinical estimate of NYHA functional status and the degree of congestive failure.
|Study Design||Observational Model: Case Control
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
|Study Population||pregnant women at least 18 years of age with a history of cardiac disease for the study group and a second group of pregnant women at least 18 years of age with no history of heart disease as controls|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status||Unknown status|
|Original Estimated Enrollment||Same as current|
|Estimated Study Completion Date||December 2011|
|Estimated Primary Completion Date||July 2011 (Final data collection date for primary outcome measure)|
Potential subjects for the cardiac disease in pregnancy cohort:
Potential subjects for pregnancy without cardiac disease cohort:
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||IRBPHS 5123|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||John J. Folk, M.D. Associate Professor, SUNY Upstate Medical University Department Obstetrics & Gynecology|
|Study Sponsor||State University of New York - Upstate Medical University|
|PRS Account||State University of New York - Upstate Medical University|
|Verification Date||August 2010|