Investigation in Pregnancy Associate Cardiomyopathy
- Conditions
- CardiomyopathyPregnancy
- Registration Number
- NCT01085955
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
Peri-partum cardiomyopathy is a heart muscle weakness that occurs during or following pregnancy. Research suggests that many initial heart injuries including viruses, pregnancy and other unknown causes, can lead to a process of inflammation of the heart muscle which can weaken the heart and cause cardiomyopathy. Why this process occurs in women during pregnancy is not well understood and if it differs from those women who develop cardiomyopathy from a virus is unknown. This study has been proposed to look at genetic information (DNA) as well as the immune system (the body's response to fight off infections and/or viruses) to find possible causes for the heart muscle damage that occurs in peripartum cardiomyopathy.
- Detailed Description
Specific Aim 1: Evaluate systemic immune activation as the etiology of PPCM. We will determine a) the degree of immune activation in PPCM and b) the relationship of autoimmunity to left ventricular dysfunction and time course of myocardial recovery, in 100 women enrolled at 30 centers. Subjects will have blood drawn for assessment of autoantibodies, and cellular immune activation at presentation, 2 month and 6 month postpartum, and will have assessment of LVEF by transthoracic echo at presentation, 2 months, 6 months and 12 months post partum. This aim will explore the hypothesis that more prolonged activation of the cellular and/or humoral immune system is associated with greater likelihood of persistent chronic cardiomyopathy.
In addition this aim will determine genetic and clinical predictors of LV recovery, and evaluate racial differences in presentation, remodeling and recovery. This study will evaluate the echo parameters of dysynchrony, diastolic function, LV size and volumes to determine echo predictors of subsequent recovery. In addition racial differences in presentation, remodeling and recovery will be investigated.
Specific Aim 2: Investigate frequency of myocardial injury or inflammation on cardiac MRI and the ability of tissue characteristics to predict subsequent recovery of LVEF. Cardiac MRI with gadolinium enhancement will be performed in 50 subjects with PPCM from Aim 1 at presentation and repeated at 6 months post partum. We will test the hypothesis is that subjects with more extensive injury (defined as % myocardium with late gadolinium enhancement) will have less recovery at 6 months.
Specific Aim 3: Establish DNA and serum to facilitate future investigations of the pathogenesis of peripartum cardiomyopathy. All subjects enrolled will have DNA, RNA from peripheral blood and serum banked at entry. Serum will be repeated at 2 and 6 months post partum.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- Patient of 16 years of age or older
- Diagnosis of peripartum cardiomyopathy
- Presentation for enrollment no earlier than one month pre-term and no later than two months post partum.
- LVEF less than OR equal to 0.45 by echocardiogram
Additional inclusion criteria for MRI substudy:
- Must be post partum
- Participant is not breast feeding or is willing to forego breast feeding for 24 hours post gadolinium.
- Previous diagnosis of cardiomyopathy, valvular disease or complex congenital heart disease
- Evidence of CAD (>50% stenosis of major epicardial vessel or positive non-invasive stress test)
- Previous cardiac transplant
- Chemotherapy or chest radiation within 5 years of enrollment
- Evidence of ongoing bacterial septicemia (positive blood cultures)
- Medical, social, or psychiatric condition which limit the ability to comply with follow-up (Example: alcohol or drug abuse)
Additional Exclusion for MRI Substudy
- GFR < 30mL/1.7 m2 by MDRD equation (http://www.kidney.org/professionals/kdogi/gfr_calculator.cfm)
- Currently breast feeding or unwilling to forego for 24 hour period post gadolinium
- Implanted devices (cochlear implants, pacemakers, defibrillators, infusion pumps, nerve stimulators, etc)
- Cerebral aneurysm clips
- Swan Ganz catheter or intra aortic balloon pump
- Ocular metal or metallic splinters in the eye
- Pregnant women
- Metal shrapnel or bullet
- Allergy to Gadolinium
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate systemic immune activation as the etiology of PPCM 6-12 months determine the degree of immune activation in PPCM and the relationship of autoimmunity to left ventricular dysfunction and time course of myocardial recovery, in 100 women enrolled at multiple centers.
- Secondary Outcome Measures
Name Time Method Investigate frequency of myocardial injury or inflammation on cardiac MRI and the ability of tissue characteristics to predict subsequent recovery of LVEF 6 months Cardiac MRI with gadolinium enhancement will be performed in 50 subjects with PPCM from Aim 1 at presentation and repeated at 6 months post partum. We will test the hypothes that subjects with more extensive injury (defined as % myocardium with late gadolinium enhancement) will have less recovery at 6 months
Trial Locations
- Locations (30)
University of Southern California
🇺🇸Los Angeles, California, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas, Southwestern
🇺🇸Dallas, Texas, United States
University of Illinois
🇺🇸Chicago, Illinois, United States
University of Miami, Miller School of Medicine
🇺🇸Miami, Florida, United States
Brigham and Women's
🇺🇸Boston, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Intermountain Medical Center
🇺🇸Salt Lake City, Utah, United States
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
Massachusetts General
🇺🇸Boston, Massachusetts, United States
Louisiana State University Health Science Center
🇺🇸Louisiana, Louisiana, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
DMC Cardiovascular Institute / Harper University Hospital
🇺🇸Detroit, Michigan, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Sir Mortimer B. Davis / Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Columbia University
🇺🇸New York City, New York, United States
Gagnon Cardiovascular Institute at Morristown Memorial Hospital
🇺🇸Morristown, New Jersey, United States
Newark Beth Israel Medical Center
🇺🇸Newark, New Jersey, United States
University of Kentucky
🇺🇸Lexington, Kentucky, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Foothills Medical Center
🇨🇦Calgary, Alberta, Canada
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States