Peripartum Cardiomyopathy Registry
Biomarker sub-protocol

Peripartum cardiomyopathy is a rare but potentially life-threatening form of
heart failure affecting women late in pregnancy or in the first months after
delivery. Peripartum cardiomyopathy is difficult to diagnose and its onset and
progression are variable between individuals. The pathophysiology remains
poorly understood, hence treatment options are limited and possibly harmful to
the foetus. Furthermore, geographical incidence varies greatly and little is
known about the incidence in Western countries. To gain further understanding
of the pathophysiology and incidence of peripartum cardiomyopathy, the European
Society of Cardiology initiated a study group to implement a registry.

The aim of the Peripartum Cardiomyopathy Registry was to describe the
demographic, clinical, and biological characteristics of outpatients and
inpatients with PPCM followed by a representative setting of cardiology
centres. The protocol of the Peripartum Cardiomyopathy (PPCM) Registry has
recently been amended to incorporate a sub-protocol that aims, through some
blood analyses, at better understanding this disease in pregnant women or
post-partum.

The purpose of the sub-study is to do research into markers which will
hopefully assist to diagnose the condition Peripartum Cardiomyopathy as early
as possible. The blood donated for research will also assist in the assessment
of women having a high risk of not recovering their
heart muscle function. This blood will be used to establish if markers of
inflammation and fibrosis contribute to the cause and progression of disease.

The PPCM Registry is a prospective, multicentre, observational study of
patients presenting to Cardiology Centres in European, Mediterranean countries
and other international centres.

The registry, on about 1000 cases of suspected PPCM, aims to collect data on
the clinical phenotype, social status, frequency, diagnosis and differential
diagnosis, forms of care and treatment of heart failure across a wide variety
of countries by internal medicine specialists or cardiologists and other
specialists who manage patients with PPCM. The Case Report Form (CRF) will be
accessed through the EORP website.

Standard management of patients will be the diagnostic and therapeutic
interventions currently performed in each centre for patients presenting with
signs and symptoms of PPCM. Drug prescriptions and indications to perform
diagnostic/ therapeutic procedures will be completely left to participating
cardiologists* decision. No specific protocols or recommendations for
evaluation, management, and/or treatment will be put forth during this
observational study.

Current sub-study:
Centres can participate in this sub-study if they have at least 10 patients and
if they have access to a freezer at -80°C for conservation of the samples. The
centres will have to store the samples for one year until the requested number
is reached. Then the samples will be shipped
all together. Blood will be collected at baseline and at 6 months.

For this study, blood samples (2 tubes, 13 mL blood) will be obtained at two
different time points. All other
investigations in this study are part of routine clinical care. Therefore,
risks for the patients can be
considered negligible.