The EURObservational Research Programme (EORP) Registry on Peripartum Cardiomyopathy (PPCM) CPP, Friday, 21th February, Venice

The EURObservational Research Programme (EORP) Registry on Peripartum Cardiomyopathy (PPCM) CPP, Friday, 21th February, Venice

Long-Term Registry on Patients with Peripartum Cardiomyopathy Executive Committee: Karen Sliwa, Chairperson Burkert Pieske, Chairperson Katrin Bachelier-Walenta Uri Elkayam Roger Hall Denise Hilfiker-Kleiner Aldo Pietro Maggioni John McMurray Alexandre Mebazaa Frederic Mouquet Mark Petrie Piotr Ponikowski Vera Regitz-Zagrosek Jolien Roos-Hesselink Maria Schaufelberger Petar Seferovic Ajay Shah Luigi Tavazzi Karin van Spaendonck-Zwart Dirk van Veldhuisen Coordinating Centre: EURObservational Research Programme 2035 Route des Colles Les Templiers, BP 179 06903 Sophia Antipolis France Tel: +33(0) 492 94 7600 Fax: +33(0) 492 94 7629

Study Group on Peripartum Cardiomyopathy Aims To establish a platform where current knowledge on peripartum cardiomyopathy based on experimental and clinical studies is summarized and regularly up-dated. To raise awareness of this uncommon but devastating problem by promoting sessions at congresses and publishing articles. To coordinate the collection and analysis of data internationally for better understanding of the condition. To meet regularly to discuss and update management strategies with a focus on novel diagnostic and therapeutic approaches. To provide information and contact addresses on our webpage for physicians and patients concerned about PPCM. To initiate and be advocates for the PPCM Registry Karen Sliwa (Cape Town, South Africa) Burkert Pieske (Graz, AT) Denise Hilfiker-Kleiner (Hannover, DE) John McMurray (Glasgow, GB) Alexandre Mebazaa (Paris, FR) Mark Petrie (Glasgow, GB) Vera Regitz-Zagrosek (Berlin, DE) Maria Schaufelberger (Gothenburg, SE) Petar Seferovic (Belgrade, RS) Ajay Shah (London, GB) Luigi Tavazzi (Cotignola, IT) Dirk van Veldhuisen (Groningen, NL) Karin van Spaendonck-Zwart (Amsterdam, NL) Uri Elkayam (Los Angeles, US) Frederic Mouquet (Lille, FR) Katrin Bachelier-Walenta (Hamburg, DE) Affilate member: Amam Mbakwem (Nigeria)

Background on PPCM Registry Study Group highlighted in the Position Paper, published 2010, the lack of data from ESC member countries

EuroObs PPCM Registry PROOFS - in press

Peripartum Cardiomyopathy Study group members contributed to new knowledge advancing the understanding of the disease MicroRNA-146a is a therapeutic target and biomarker for peripartum cardiomyopathy Julie Halkein, Sebastien P. Tabruyn, Karen Sliwa, Denise Hilfiker-Kleiner,Ingrid Struman et al April 2013 The Journal of Clinical Investigation. More information at www.jci.org/articles/view/64365

ESC HFA PPCM Registry Start: May 2012 Aim: 1000 patients European Society of Cardiology Members Countries Background 1. Proposal for a PPCM Registry was submitted in 2011. 2. Protocol finalized and start of Registry in May 2012 3. Recruitment status as of February 2014: 145 patients

PPCM Registry The electronic Case Report Form can be accessed through the website of the EURObservational Research Programme (EORP): www.eorp.org To register and obtain login codes to access the EORP website, please contact the EORP department: eorp@escardio.org The front page contain the mandatory key questions qualifying a patient as potential PPCM: 1. Peripartum stage 2. Signs and/ or symptoms of heart failure 3. Ejection fraction <45% 4. Other causes of heart failure excluded This will ensure that mainly patients with suspected PPCM will be entered.

Peripartum Cardiomyopathy Registry Recruitment status as of February 10 th, 2014 www.eorp.org 93 participating centres across 42 countries At least 1 patient enrolled No patient enrolled so far (Centres awaiting EC approval and/or patients with PPCM)

. Peripartum Cardiomyopathy Registry Progression of recruitment as of February 10 th, 2014 145 patients enrolled 100 90 80 70 60 50 40 30 20 10 0 43 active centres 93 participating centres

40 35 40 Peripartum Cardiomyopathy Registry Recruitment status as of February 10 th, 2014 145 Patients Enrolled by 43 Active Centres across 27 Countries 30 25 20 19 145 Patients Enrolled 120 Patients Completed 48 Patients Locked 15 10 5 12 9 9 6 5 5 4 4 4 3 3 3 3 2 2 2 2 1 1 1 1 1 1 1 1 0

. Peripartum Cardiomyopathy Registry Baseline Characteristics (1/2) Item N All n ESC n Non ESC Age 30.7±0.6 Median=30.2 Q1=25.2, Q3=35.6 30.7±0.8 Median=30.2 Q1=24.7, Q3=35.8 30.8±1.0 Median=30.3 Q1=25.8, Q3=35.3 Parity: Gravida 3.4±0.2 3.7±0.3 3.1±0.3 Parity: Para 3.0±0.2 3.1±0.3 2.9±0.3 Heart Rate (ECG) 104.1±2.0 104.0±2.7 104.1±2.8 Systolic Blood Pressure (mmhg) 119.9±2.4 120.4±2.9 118.6±4.2 Diastolic Blood Pressure (mmhg) 76.9±1.6 76.3±1.9 78.5±2.6 Left Ventricular End Systolic dimension (mm) Left Ventricular End Diastolic dimension (mm) Ejection fraction 1. Teichholz (EF1) - % Ejection fraction 2. Visual estim. (EF2) - % 51.0±0.9 50.2±1.3 52.1±1.4 60.8±0.7 60.8±0.9 60.9±1.3 32.0±1.1 32.9±1.4 30.7±1.6 30.2±1.0 30.7±1.2 29.3±1.8 Haemoglobin (g/dl) 11.6±0.2 11.2±0.2 12.2±0.4

. Peripartum Cardiomyopathy Registry Baseline Characteristics (2/2) Item n All % n ESC % N Non ESC % Diabetic 3.3 3.8 2.3 Smoking Current + Former 10.7 15.2 2.3 HIV status YES 2.5 0 7 HIV status Unknown 32.3 47.4 4.7 Hypertension during current pregnancy: Yes 19.7 25.3 9.3 Hypertension during current pregnancy: Unknown 1.6 1.3 2.3 Pre-eclampsia: Yes 14.8 19 7 Pre-eclampsia: Unknown 4.1 5.1 2.3 NYHA class I and II 32.8 25.3 46.5 NYHA class III and IV 67.2 74.7 53.5 Dyspnea 89.3 88.6 90.7 S3 gallop 46.7 39.2 60.5 JVP(>6cm) 48.8 43.6 58.1 Mitral regurgitation 54.9 57.0 51.1 Beta-blockers ( pre-diagnosis) 13.2 7.7 23.7 Bromocriptine drugs ( pre-diagnosis) 4.1 1.3 9.3 Diuretics oral ( pre-diagnosis) 13.2 6.4 25.6

. Peripartum Cardiomyopathy Registry Most frequent queries PAGE SECTION QUERIES 2.1. Physical Indications Heart Rate value is missing Blood Pressure systolic and diastolic are missing Investigation 2.2. Basic Information Doppler Diastolic Function Assessment QRS-duration: value not reported Intra ventricular septum systole dimension: value is missing Ejection fraction 2 visual estimation (EF2): value is missing Outcome 2.3. Chemistry Blood Sample 5.2. Conditions PPCM diagnosis 5.3. Neonate details Platelets: check units! When was the diagnosis of PPCM made: (x) should be between 6 months before Visit date and 6 months after Visit date (y) Head circumference: value is missing & unavailable Length of the neonate: value is missing & unavailable Agpar score at 5 min: value is missing & unavailable

Peripartum Cardiomyopathy Creating awareness for the condition and the registry Promoting the registry via lectures given Referring to the PPCM Registry in publications http://www.escardio.org/communities/hfa/committees/peripartum-cardiomyopathy/pages/welcome.aspx Interested talking part in the PPCM or ROPAC Registry? Please join us at meeting 4.00-6.00 pm Please enter cases and complete the Follow Up pages at 6 Month and One Year!!!