Investigation in Pregnancy Associate Cardiomyopathy



Status:Completed
Conditions:Cardiology, Women's Studies
Therapuetic Areas:Cardiology / Vascular Diseases, Reproductive
Healthy:No
Age Range:16 - Any
Updated:4/21/2016
Start Date:October 2009
End Date:August 2014

Use our guide to learn which trials are right for you!

Immune Activation and Myocardial Recovery in Peripartum Cardiomyopathy

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.

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.

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
We found this trial at
29
sites
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
?
mi
from
Miami, FL
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
Los Angeles, California 90033
213) 740-2311
University of Southern California The University of Southern California is one of the world’s leading...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
1 Brookings Drive
St. Louis, Missouri 63110
 (314) 935-5000
Washington University Washington University creates an environment to encourage and support an ethos of wide-ranging...
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
598 Telfair Street
Augusta, Georgia 30912
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Baltimore, Maryland 21218
(410) 516-8000
Johns Hopkins The Johns Hopkins University opened in 1876, with the inauguration of its first...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Calgary, Alberta
?
mi
from
Calgary,
Click here to add this to my saved trials
1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Univ of Illinois A major research university in the heart of one of the world's...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
?
mi
from
Hershey, PA
Click here to add this to my saved trials
Lexington, Kentucky
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
?
mi
from
Lexington, KY
Click here to add this to my saved trials
?
mi
from
Louisiana, LA
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
New York City, New York 10032
?
mi
from
New York City, NY
Click here to add this to my saved trials
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Rochester, Minnesota 55905
?
mi
from
Rochester, MN
Click here to add this to my saved trials
Salt Lake City, Utah 84157
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
101 Nicolls Rd
Stony Brook, New York 11794
(631) 444-4000
Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
?
mi
from
Stony Brook, NY
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials