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FACULTY ACADEMY SLEIGHT Peter, Oxford, GBR ABRAHAM William T., Columbus, USA SOBHY Mohamed, Alexandria, EGY ADAMS Kirkwood, Chapel Hill, USA STAELS Bart, Lille, FRA AGEWALL Stefan, Oslo, NOR STROES Eric, Amsterdam, NED AKEHURST Ron, Sheffield, GBR SWYNGHEDAUW Bernard, Paris, FRA ANKER Stefan, Berlin, GER TARDIF Jean-Claude, Montréal, CAN AZIZI Michel, Paris, FRA TAVAZZI Luigi, Cotignola, ITA BAIGENT Colin, Oxford, GBR TAWAKOL Ahmed, Boston, USA BAKRIS George, Chicago, USA TORP-PEDERSEN Christian, Copenhagen, DEN BEYGUI Farzin, Paris, FRA TSCHOEPE Carsten, Berlin, GER BLANKENBERG Stefan, Hamburg, GER VERHEUGT Freek, Amsterdam, NED BORER Jeffrey, New York, USA VOORS Adrian, Groningen, NED BRUTSAERT Dirk L, Antwerp, BEL WACHTER Rolf, Göttingen, GER CALVO Gonzalo, Barcelona, ESP WAHL Denis, Nancy, FRA CASAS Juan Pablo, London, GBR WARNOCK David, Birmingham, USA CHOUDHURY Robin, Oxford, GBR WASSMANN Sven, Munich, GER CLELAND John, Hull, GBR WHEELER David, London, GBR CLEMMENSEN Peter, Copenhagen, DEN WIERZBICKI Anthony, London, GBR COHEN-SOLAL Alain, Paris, FRA ZANNAD Faiez, Nancy, FRA COWIE Martin, London, GBR DAN George-Andrei, Bucharest, ROM DE FERRARI Gaetano, Pavia, ITA EMEA–FDA–NHLBI-PMDA-MHRA DREXEL Heinz, Feldkirch, AUS ANDO Yuki, PMDA, JAP DUNLAP Stephanie, Chicago, USA ALONSO Angeles, EMEA, ESP EZEKOWITZ Justin, Edmonton, CAN BONDS Denise, NHLBI, USA FAYAD Zahi, New York, USA COOK Nakela, NHLBI, USA FELKER Michael, Durham, USA DE GRAEF Pieter, EMEA, NED FIUZAT Mona, Durham, USA DUNDER Kristina, EMEA, SWE GAMRA Habib, Monastir, TUN FARB Andrew, FDA, USA GHEORGHIADE Mihai, Chicago, USA GELLER Nancy, NHLBI, USA GIBSON Michael, Boston, USA GORDON David, NHLBI, USA GIRERD Nicolas, Nancy, FRA HEMMINGS Robert, MHRA, GBR GOLDSMITH David, London, GBR MASCETTE Alice, NHLBI, USA HALLER Hermann, Hannover, GER PRASAD Krishna, MHRA, GBR HARDMAN Suzanna, London, GBR ROSANO Giuseppe, EMEA, ITA HERNANDEZ Adrian, Durham, USA ROSENBERG Yves, NHLBI, USA HOFFMANN Udo, Boston, USA SHINAGAWA Kaori, PMDA, JAP JARCHO John, Boston, USA JANUZZI Jim, Boston, USA KASKI Juan Carlos, London, GBR INDUSTRY KJELDSEN Keld, Copenhagen, DEN ADOURIAN Aram, BG Medicine, USA KJELDSEN Sverre E., Oslo, NOR AUDHYA Paul, Reata, USA KOENIG Wolfgang, Ulm, GER BERKOWITZ Scott, Bayer, USA LEWIS Basil, Haïfa, ISR BUYSSE Jerry, Relypsa, USA LINDE Cecilia, Stockholm, SWE CARLSON Mark, St Jude Medical, USA LOSCALZO Joseph, Boston, USA CODY Robert, J&J, USA MAGGIONI Aldo, Florence, ITA DELIARGYRIS Efthymios, The Medicines Company, USA MAHFOUD Felix, Homburg, GER FRIEDMAN Jeffrey, Boehringer Ingelheim, USA MARRE Michel, Paris, FRA GAUDIN Christophe, Sanofi, FRA MARTINEZ Felipe, Cordoba, ARG GOBBI Giorgio, Medtronic, CHE MASSY Ziad, Boulogne-Billancourt, FRA HASKEL Lloyd, J&J, USA MEBAZAA Alexandre, Paris, FRA HOUDIJK Wim, Biomérieux, FRA MEHRAN Roxana, New York, USA KHDER Yasser, Boehringer Ingelheim, FRA METRA Marco, Brescia, ITA KIEVAL Rob, CVRx, USA NARULA Jagat, New York, USA KIM Jae, Amgen, USA O’CONNOR Christopher, Durham, USA KOGLIN Joerg, Merck, USA PAIS Prem, Bangalore, IND KUPFER Stuart, Takeda, USA PATHAK Atul, Toulouse, FRA LASALVIA Luis, Siemens, USA PEACOCK Frank, Cleveland, USA LAWRENCE John, BMS, USA PFEFFER Marc, Boston, USA MENDELSOHN Michael, Merck, USA PIÑA Ileana, New York, USA MIX Chris, Amgen, USA PITT Bertram, Ann Arbor, USA ROESSIG Lothar, Bayer, GER POCOCK Stuart, London, GBR SCOTT Robert, Amgen, USA RAY Kausik, London, GBR SEMJONOW Véronique, Philips, NED REDBERG Rita, San Francisco, USA SHIPMAN Tami, St Jude Medical, USA ROSENSON Robert, New York, USA SNIDER James, Critical Diagnostics, USA ROSSI Gian Paolo, Padua, ITA STEIN Kenneth, Boston Scientific, USA ROSSIGNOL Patrick, Nancy, FRA TAIEL-SARTRAL Magali, Lilly, FRA ROUSSEL Ronan, Paris, FRA TSOUDEROS Yannis, Servier, FRA RUDD James, Cambridge, GBR VINCENT Alphons, Medtronic, CHE RUILOPE Luis, Madrid, ESP YADAV Jay, CardioMEMS, USA SILVAIN Johanne, Paris, FRA YARED Nadim, CVRx, USA SIMON Tabassome, Paris, FRA WASSERMAN Scott, Amgen, USA SIMOONS Maarten, Rotterdam, NED WOEHRLE Holger, ResMed, GER 2 9th Global CardioVascular Clinical Trialists Forum • Paris 2012 GENERAL PRESENTATION Organized in collaboration with the European Society of Cardiology Working Group on Cardiovascular Pharmacology and Drug Therapy, CVCT Forum is a meeting specifically and totally dedicated to the discussion of clinical trials in cardiovascular disease. CVCT Forum is attended by experts principally engaged in cardiovascular clinical trials (hence it’s name). Participants are among the group of major international opinion leaders and come from various functions linked with primary care, pharmaceutical industry, pharmaceutical regulatory bodies, and publishing houses from around the world (US, Canada, Asia, Europe, and Japan). An outstanding faculty members are committed to disseminating concise data from controlled clinical trials that contribute to better clinical care and to discussing and identifying issues and relevant information. Such as how to do better clinical trials, how to satisfy regulatory authorities, and most importantly, how to improve cardiovascular health care. The CVCT meetings are ‘grass root’ meetings, attended by individuals who are eager to communicate with one another and to share experiences with primary care physicians and the people that create and analyze major trials. CVCT meetings are primarily oriented toward discussion among persons as opposed to lecturing to a broad audience. Thought process counts, communication (during the meeting, but more importantly informal discussions outside of the meeting) is the important agenda, as opposed to dictating doctrine. The format of the meeting is set to fulfill these aims. Beyond plenary sessions the meeting is structured with a variety of small interactive brainstorming workshops, expert discussions and consensus building workshops. The discussion takes place with a selected audience of opinion leaders, clinical trialists, pharmaceutical industry partners, regulators, investigators and cardiologists. CVCT Forum aims to: ■ Familiarize practitioners and young investigators with the science of clinical trials from trial protocol design to trial result interpretation ■ Examine the background of knowledge which led to the design of major trials ■ Identify and understand best evidence from clinical trials ■ Examine the consequences of trial results on the updating of guidelines ■ Consider the consequences and relative weight of Evidence based vs Mechanism based and Marketing based medicine ■ Identify emerging important issues in cardiovascular medicine ■ Examine opportunities and needs for new trials We do hope that you will share with us the excitement of this unique learning experience and we are very happy to welcome you in Paris. Pr. Faiez ZANNAD Dr. Bertram PITT 9th Global CardioVascular Clinical Trialists Forum • Paris 2012 3 SUMMARY SCIENTIFIC PROGRAM PROGRAM AT A GLANCE .......................................................................................... 5 Friday November 30th ....................................................................................................... 6 Saturday December 1st ....................................................................................................... 12 CVCTlive Sessions ............................................................................................................. 20 CVCT YOUNG TRIALISTS MENTORING .................................................................. 22 CVCT RESSOURCE CENTER ..................................................................................... 22 EUROPEAN BOARD FOR ACCREDITATION IN CARDIOLOGY ........................... 22 ENDORSING PARTNERS ............................................................................................ 23 SPEAKERS BIOGRAPHIES & ABSTRACTS .............................................................. 25 POSTERS ...................................................................................................................... 65 GENERAL INFORMATION .......................................................................................... 71 th 4 4 9 th Global 9 Global Cardio CardioVascularVascular Clinical Clinical Trialists Trialists Forum Forum • Paris • Paris 2012 2012 PROGRAM AT A GLANCE FRIDAY NOVEMBER 30, 2012 PARIS / CET 08:00 am - 10:00 am 10:20 am - 12:30 am 12:45 am - 03:15 pm 03:30 pm - 05:00 pm 05:20 pm - 07:30 pm LUNCH DEBATE WORKSHOP 1 WORKSHOP 1 SESSION 1 WORKSHOP 2 WORKSHOP 2 THE THE ATHEROSCLEROSIS ATHEROSCLEROSIS THE DEVICE MODIGLIANI THROMBOSIS THROMBOSIS IMAGING IMAGING THERAPY TRIALISTS TRIALISTS IN CLINICAL IN CLINICAL TRIALISTS TRIALS TRIALS WORKSHOP K WORKSHOP K K WORKSHOP REA REA REA B B B XES SERVED EE EE EE BO COFF LUNCH DEBATE COFF COFF LUNCH SESSION 2 NEW EVIDENCE, WORKSHOP 4 WORKSHOP 4 WORKSHOP 3 WORKSHOP 3 NEW GUIDELINES CARDIOVASCULAR CARDIOVASCULAR SOUTINE / THE DIABETES THE DIABETES & PREVENTION PREVENTION UTRILLO TRIALISTS TRIALISTS FUTURE IN CHRONIC IN CHRONIC WORKSHOP WORKSHOP DEVELOPMENTS WITH IVABRADINE KIDNEY DISEASE KIDNEY DISEASE SATELLITE SYMPOSIUM SATURDAY DECEMBER 1, 2012 PARIS / CET 08:00 am - 10:00 am 10:20 am - 12:30 am 12:45 am - 03:15 pm 03:30 pm - 05:00 pm 05:20 pm - 07:30 pm DEBATE DEBATE WORKSHOP 5 WORKSHOP 5 LUNCH DEBATE SESSION 4 SESSION 5 THE THE SESSION 3 HEART FAILURE MODIGLIANI ATHEROSCLEROSIS ATHEROSCLEROSIS HEART FAILURE NOVEL DIURETIC REMOTE TRIALISTS TRIALISTS TRIALISTS STRATEGIES MONITORING IN HEART FORUM FORUM WORKSHOP k K TRIALS K FAILURE