Investigation in Pregnancy Associate 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