Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease - Full Text View

Sponsors and Collaborators:	State University of New York - Upstate Medical University Crouse Hospital Central New York Community Foundation, Inc.
Information provided by:	State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:	NCT00759733

Purpose

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.

Condition	Intervention
Pregnancy Heart Diseases	Procedure: echocardiography Procedure: blood draw for serum B-type natriuretic peptide

MedlinePlus related topics: Heart Disease in Women Heart Diseases

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
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

Further study details as provided by State University of New York - Upstate Medical University:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Pregnant women with a history of cardiac disease (study group)	Procedure: echocardiography A non-invasive assessment of cardiac function using sound waves to create a picture of the pregnant woman's heart. There is no radiation involved. Procedure: blood draw for serum B-type natriuretic peptide A simple, minimally invasive standard blood draw for assessment of serum B-type natriuretic peptide, to be measured in a standard hospital laboratory and recorded for research purposes only
2 Pregnant women with no history of heart disease (control group)	Procedure: echocardiography A non-invasive assessment of cardiac function using sound waves to create a picture of the pregnant woman's heart. There is no radiation involved. Procedure: blood draw for serum B-type natriuretic peptide A simple, minimally invasive standard blood draw for assessment of serum B-type natriuretic peptide, to be measured in a standard hospital laboratory and recorded for research purposes only

Groups/Cohorts

Assigned Interventions

1

Pregnant women with a history of cardiac disease (study group)

Procedure: echocardiography

A non-invasive assessment of cardiac function using sound waves to create a picture of the pregnant woman's heart. There is no radiation involved.

Procedure: blood draw for serum B-type natriuretic peptide

A simple, minimally invasive standard blood draw for assessment of serum B-type natriuretic peptide, to be measured in a standard hospital laboratory and recorded for research purposes only

2

Pregnant women with no history of heart disease (control group)

Procedure: echocardiography

A non-invasive assessment of cardiac function using sound waves to create a picture of the pregnant woman's heart. There is no radiation involved.

Procedure: blood draw for serum B-type natriuretic peptide

A simple, minimally invasive standard blood draw for assessment of serum B-type natriuretic peptide, to be measured in a standard hospital laboratory and recorded for research purposes only

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00759733

Contacts

Contact: John J Folk, MD

315-464-4736

folkj@upstate.edu

Locations

United States, New York
Regional Perinatal Center
Syracuse, New York, United States, 13202
Cardiology Associates Central New York Physician Office Building
Syracuse, New York, United States, 13210

Sponsors and Collaborators

State University of New York - Upstate Medical University

Crouse Hospital

Central New York Community Foundation, Inc.

Investigators

Principal Investigator:

John J Folk, MD

State University of New York - Upstate Medical University

More Information

Publications:

McAnulty JH, Metcalfe J, Ueland K. Heart disease in pregnancy. Hurst JW, Schlant RC, Rockley CE, et al. (eds) The Heart: Arteries and Veins, 7th Edition. McGraw-Hill Information Services, New York 1990; 1465-1478.

Lupton M, Oteng-Ntim E, Ayida G, Steer PJ. Cardiac disease in pregnancy. Curr Opin Obstet Gynecol. 2002 Apr;14(2):137-43. Review.

Clark SL, Cotton DB, Lee W, Bishop C, Hill T, Southwick J, Pivarnik J, Spillman T, DeVore GR, Phelan J, et al. Central hemodynamic assessment of normal term pregnancy. Am J Obstet Gynecol. 1989 Dec;161(6 Pt 1):1439-42.

Maisel AS, Krishnaswamy P, Nowak RM, McCord J, Hollander JE, Duc P, Omland T, Storrow AB, Abraham WT, Wu AH, Clopton P, Steg PG, Westheim A, Knudsen CW, Perez A, Kazanegra R, Herrmann HC, McCullough PA; Breathing Not Properly Multinational Study Investigators. Rapid measurement of B-type natriuretic peptide in the emergency diagnosis of heart failure. N Engl J Med. 2002 Jul 18;347(3):161-7. Summary for patients in: J Fam Pract. 2002 Oct;51(10):816.

Borghi C, Esposti DD, Immordino V, Cassani A, Boschi S, Bovicelli L, Ambrosioni E. Relationship of systemic hemodynamics, left ventricular structure and function, and plasma natriuretic peptide concentrations during pregnancy complicated by preeclampsia. Am J Obstet Gynecol. 2000 Jul;183(1):140-7.

Folk JJ, Lipari CW, Nosovitch JT, Silverman RK, Carlson RJ, Navone AJ. Evaluating ventricular function with B-type natriuretic peptide in obstetric patients. J Reprod Med. 2005 Mar;50(3):147-54.

Clark SL. Structural cardiac disease in pregnancy. Clark SL, Cotton DB, Phelan JP (eds). Critical Care Obstetrics, Medical Economics Books, Oradell, New Jersey 1987; 92-113.

Responsible Party:	SUNY Upstate Medical University Department Obstetrics & Gynecology ( John J. Folk, M.D. Associate Professor )
Study ID Numbers:	IRBPHS 5123
Study First Received:	September 24, 2008
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00759733 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:

pregnancy
heart disease
heart function testing

echocardiography
B-type natriuretic peptide
obstetrical care

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Diseases
Cardiovascular Agents

Additional relevant MeSH terms:

Natriuretic Peptide, Brain
Heart Diseases
Natriuretic Agents
Therapeutic Uses

Physiological Effects of Drugs
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009