Investigation in Pregnancy Associate Cardiomyopathy

Completed

Conditions studied: Cardiomyopathy, Pregnancy

In brief

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.

Key facts

Study ID

NCT01085955

Run by

University of Pittsburgh

People needed

100

Starts

2009-10-01

Expected to finish

2014-08-01

Last updated by the study team

2016-01-15

Who can join

Age: 16 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Southern California — Los Angeles, California, United States
• University of Miami, Miller School of Medicine — Miami, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Illinois — Chicago, Illinois, United States
• University of Kentucky — Lexington, Kentucky, United States
• Louisiana State University Health Science Center — Louisiana, Louisiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Massachusetts General — Boston, Massachusetts, United States
• Brigham and Women's — Boston, Massachusetts, United States
• DMC Cardiovascular Institute / Harper University Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Gagnon Cardiovascular Institute at Morristown Memorial Hospital — Morristown, New Jersey, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Stony Brook University Medical Center — Stony Brook, New York, United States
• Duke University — Durham, North Carolina, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Penn State Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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