Evaluation Cardiac Function With Echo and BNP in Obstetrical Patients With/Without Cardiac Disease

NCT00759733 | Withdrawn

• 1 other identifier: IRBPHS 5123
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Pregnancy; Heart Diseases

Keywords

pregnancy; heart disease; heart function testing; echocardiography; B-type natriuretic peptide; obstetrical care

Outcome Measures

Primary Outcomes (1)

• 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

  first, second, third trimesters of a 40-week pregnancy

Secondary Outcomes (1)

• Assess for the presence of cardiac dysfunction in the course of a 40-week pregnancy

  first, second, third trimesters of pregnancy

Study Arms (2)

1

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

Procedure: echocardiography; Procedure: blood draw for serum B-type natriuretic peptide

2

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

Procedure: echocardiography; Procedure: blood draw for serum B-type natriuretic peptide

Interventions

echocardiography PROCEDURE

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.

Also known as: echocardiogram

1; 2

blood draw for serum B-type natriuretic peptide PROCEDURE

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

Also known as: BNP

1; 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Crouse Hospital: collaborator
• Central New York Community Foundation, Inc.: collaborator

Study Sites (2)

Regional Perinatal Center

Syracuse, New York, 13202, United States

Location

Cardiology Associates Central New York Physician Office Building

Syracuse, New York, 13210, United States

Location

Related Publications (7)

• 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.

  BACKGROUND

• Lupton M, Oteng-Ntim E, Ayida G, Steer PJ. Cardiac disease in pregnancy. Curr Opin Obstet Gynecol. 2002 Apr;14(2):137-43. doi: 10.1097/00001703-200204000-00006.

  PMID: 11914690 BACKGROUND

• 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. doi: 10.1016/0002-9378(89)90900-9.

  PMID: 2603895 BACKGROUND

• 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. doi: 10.1056/NEJMoa020233.

  PMID: 12124404 BACKGROUND

• 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. doi: 10.1067/mob.2000.105684.

  PMID: 10920322 BACKGROUND

• 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.

  PMID: 15841926 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• John J Folk, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

US (2)