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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by State University of New York - Upstate Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Crouse Hospital
Central New York Community Foundation, Inc.
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00759733
First received: September 24, 2008
Last updated: August 4, 2010
Last verified: August 2010
  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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: 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

Resource links provided by NLM:


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 ]

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.
Other Name: echocardiogram
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
Other Name: BNP
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.
Other Name: echocardiogram
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
Other Name: BNP

  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:

  1. At least 18 years of age
  2. 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)
  3. Other significant cardiac disease not listed above
  4. Other medical disorders, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders, et cetera, will be acceptable
  5. Diagnosis of a least a single intrauterine pregnancy, multiple gestation acceptable

Potential subjects for pregnancy without cardiac disease cohort:

  1. At least 18 years of age
  2. Absence of significant cardiac disease, minor cardiac disorders such as mitral valve prolapse without arrythmia
  3. Other medical disorders, not directly related to cardiac disease, such as diabetes mellitus, chronic hypertension, asthma, other endocrine disorders et cetera, will be acceptable
  4. Diagnosis of at least a single intrauterine pregnancy, multiple gestation acceptable

Exclusion Criteria:

  1. Less than 18 years of age
  2. Non-viable pregnancy such as a threatened spontaneous miscarriage, or ectopic pregnancy
  3. Planned termination of pregnancy, either elective or medically indicated based on history
  4. 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 Not yet recruiting
Syracuse, New York, United States, 13202
Contact: John J Folk, MD    315-464-4736    folkj@upstate.edu   
Contact: Mary P Drexler, RN    315-464-4458      
Principal Investigator: John J Folk, MD         
Sub-Investigator: Richard H Aubry, MD MPH         
Cardiology Associates Central New York Physician Office Building Not yet recruiting
Syracuse, New York, United States, 13210
Contact: Martha Castle, RN    315-470-7409      
Sub-Investigator: Raymond J Carlson, MD         
Sub-Investigator: Anthony Navone, MD         
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.
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: John J. Folk, M.D. Associate Professor, SUNY Upstate Medical University Department Obstetrics & Gynecology
ClinicalTrials.gov Identifier: NCT00759733     History of Changes
Other Study ID Numbers: IRBPHS 5123
Study First Received: September 24, 2008
Last Updated: August 4, 2010
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

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014