Thursday December 2nd, 2010 | |||
09:00-13:30 | SALON ORSAY SUD ROOM | ||
1ST INTERNATIONAL MEETING OF THE FRENCH SOCIETY OF CARDIOLOGY WORKING GROUP ON CARDIOVASCULAR PHARMACOLOGY AND DRUG THERAPY - French speaking session Nucleus Business Meeting |
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Présidents: Pierre GIBELIN, Nice - Atul PATHAK, Toulouse, FRA | |||
09:00-10:00 | Diabetes medication: what the cardiologist should know Anti-diabétiques oraux et pathologie cardiovasculaire: ce que le cardiologue doit savoir |
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Chairman: Laurent MONASSIER, Strasbourg, FRA | |||
Oldies but goldies: benefit/risk of standard diabetes medication Les «anciens» anti-diabétiques oraux: Bénéfices / risques cardiovasculaires |
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Paul VALENSI, Paris, FRA - [Presentation] | |||
GLP1, DPP IV and others… new target and indication of newcomers Les «nouveaux» hypoglycemiants oraux (GLP1, DPPIV, autres): nouvelles cibles, effets cardiovasculaires |
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François DIEVARTI , Lille, FRA [Presentation] | |||
10:00-11:00 | Keep your heart in mind / Médicaments neurologiques / psychiatriques et maladies cardiovasculaires | ||
Chairman: Pierre AMBROSI, Marseille, FRA | |||
Cardiovascular effects of anticholinesterase drugs Effets cardiovasculaires des inhibiteurs des anticholinesterases |
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Laurent MONASSIER , Strasbourg, FRA [Presentation] Michèle Escande ORTHLIEB, Allauch, FRA |
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- Introduction et rappels pharmacologiques Laurent Monassier , Strasbourg, FRA [Presentation] - Effets délétères Michèle Escande ORTHLIEB, Allauch, FRA[Presentation] - Effets bénéfiques et conclusions Laurent MONASSIER , Strasbourg, FRA |
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Cardiac effects of antipsychotic medications / Effets cardiovasculaires des traitements anti-psycotiques | |||
Milou DRICI, Nice, FRA [Presentation] | |||
11:30-12:30 | When cancer drugs affect the heart / Traitements oncologiques et coeur | ||
Chairman: Gérard ROUL, Strasbourg | |||
Cardiotoxicity of chemotherapy medications / Chimiothérapie et cardiotoxicité | |||
Pierre GIBELIN, Nice, FRA [Presentation] | |||
Antiangiogenic therapy and hypertension / Médicaments anti-angiogéniques et HTA | |||
Atul PATHAK, Toulouse, FRA | |||
TNF alpha: the cardiologist’s point of view / Le cardiologue et les immunosuppresseurs | |||
Pierre AMBROSI, Marseille, FRA [Presentation] | |||
12:30-13:30 | Vasodilating / Traitements urologiques / sexuel et coeur | ||
Chairman: François DIEVARTI, Lille, FRA | |||
Alpha Blocker and the Heart / Alpha-bloquants chez le cardiaque | |||
Pascal PONCELET, Henin Beaumont, FRA [Presentation] | |||
Clinical use of Phosphodiesterase-5 inhibitors in chronic heart failure Inhibition de la phosphodiéstérase 5 chez l’insuffisant cardiaque chronique |
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Gérard ROUL, Strasbourg, FRA [Presentation] | |||
12:30-14:00 | FOYER ORSAY NORD ROOM | ||
ESC WORKING GROUP ON PHARMACOLOGY AND DRUG THERAPY NUCLEUS BUSINESS MEETING | |||
14:00-16:00 | SALON ORSAY SUD ROOM | ||
PLENARY SESSION OPTIMIZING THE RISK TO BENEFIT RATIO WITH NEW REVERSIBLE ANTIPLATELET THERAPIES IN ACUTE CORONARY SYNDROMES |
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Chairmen: Dan ATAR, Oslo, NOR - Lars WALLENTIN, Uppsala, SWE | |||
Current guidelines and unmet needs in the management of thrombotic events in acute coronary syndromes | |||
Nicolas DANCHIN, Paris, FRA | |||
New reversible antiplatelet drugs. Pharmacology and potential advantages | |||
Steen HUSTED, Arhus, DEN | |||
The mechanisms of the mortality benefit of ticagrelor therapy. Adenosine mediated mechanisms beyond antiplatelet effects. | |||
Victor SEREBRUANY, Towson, USA [Presentation] | |||
PLATelet inhibition and patient outcomes with ticagrelor or Clopidogrel (PLATO). Practical consideration | |||
Lars WALLENTIN, Uppsala, SWE [Presentation] | |||
14:00-16:00 | SALON ORSAY NORD ROOM | ||
EXPERT WORKSHOP BIOMARKERS TO GUIDE THERAPY IN HEART FAILURE PATIENTS - IS THE CONCEPT PROVEN? |
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Chairmen: Lawrence FINE, Bethesda, USA - Alain COHEN SOLAL, Paris, FRA | |||
Why do we need biomarkers in the heart failure patient? | |||
Stephan VON HAEHLING, Berlin, GER | |||
What to monitor? Defining the right biomarker to prompt action | |||
James JANUZZI, Boston, USA [Presentation] | |||
What is the evidence that biomarker guided therapy is useful? | |||
Hans Peter BRUNNER LA ROCCA, Maastricht, NED [Presentation] | |||
Debate: The challenge of designing biomarker guided therapy trials. Optimization algorithms, endpoint and blinding issues, safety concerns. | |||
Panellists: Kirkwood ADAMS, Chapel HILL, USA - Hans Peter BRUNNER LA ROCCA, Maastricht, NED - Jay COHN, Minneapolis, USA - John CLELAND, Hull, GBR - Robert CODY, Merck, USA - Alain COHEN SOLAL, Paris, FRA Kenneth DICKSTEIN, Stavanger, NOR - Daniela DOBRE, Nancy, FRA - Lawrence FINE, Bethesda, USA Mona FIUZAT, Durham, USA - James JANUZZI, Boston, USA - Mihai GHEORGHIADE, Chicago, USA Patrick JOURDAIN, Pontoise, FRA - Ursula-Henrike WIENHUES-Thelen , Roche Diagnostics, GER Keld KJELDSEN, Copenhagen, DEN - Damien LOGEART, Paris, FRA - Aldo MAGGIONI, Firenze, ITA Alice MASCETTE, Bethesda, USA - Christian MÜELLER, Basel, SUI - Ileana PIÑA, Cleveland, USA Bernard SWYNGHEDAUW, Paris, FRA - Patrick ROSSIGNOL, Nancy, FRA - Hani SABBAH, Detroit, USA Luigi TAVAZZI, Cotignola, ITA - Harald SCHMIDT, Maastricht, NED - Stephan VON HAEHLING, Berlin, GER David WHEL LAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA - Christian ZAUGG, Roche Diagnostics, SUI |
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16:30-19:00 | SALON ORSAY NORD ROOM | ||
EXPERT WORKSHOP MYOCARDIAL INNERVATION IMAGING. FROM PROGNOSTICATION TO GUIDING THERAPY |
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Chairmen: Denis AGOSTINI, Caen, FRA - Ileana PIÑA, Cleveland, USA | |||
Myocardial imaging for assessment of cardiovascular risk in heart failure patients. From retrospective observations to prospective validation (ADMIRE-HF) |
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Paolo G. CAMICI , London, GBR [Presentation] | |||
MIBG myocardial imaging to predict ventricular arrhythmias and cardiac outcome | |||
Arnold JACOBSON, GE Healthcare, USA | |||
Cardiac MIBG imaging guided therapy in heart failure patients. Time for a trial? | |||
Ileana PIÑA, Cleveland, USA [Presentation] | |||
EXPERT WORKSHOP How to turn a prognostic factor into a therapeutic decision and monitoring tool? Design and methodological issues. |
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Panellists: Stefan AGEWALL, Stockholm, SWE - Denis AGOSTINI, Caen, FRA - Paolo G. CAMICI, London, GBR John CLELAND, Hull, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Daniela DOBRE, Nancy, FRA Lawrence FINE, Bethesda, USA - Mihai GHEORGHIADE, Chicago, USA - Arnold JACOBSON, GE Healthcare, USA James JANUZZI, Boston, USA - Henry KRUM, Melbourne, AUS - Keld KJELDSEN, Copenhagen, DEN,- Alice MASCETTE, Bethesda, USA - John McMURRAY, Glasgow, GBR - Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT , Ann ARBOR, USA - Frank RUSCHITZKA, Zurich, SUI - Aldo MAGGIONI, Florence, ITA - Atul PATHAK, Toulouse, FRA - Luigi TAVAZZI, Cotignola, ITA - Patrick ROSSIGNOL, Nancy, FRA - David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA |
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16:30-18:30 | SALON ORSAY SUD ROOM | ||
PLENARY SESSION RISK GUIDED CARDIOVASCULAR PREVENTIVE DRUG THERAPY - FROM INDIVIDUAL RISK FACTORS TO RISK SCORING |
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Chairmen: Luis RUILOPE, Madrid, ESP - Faiez ZANNAB, Nancy, FRA | |||
Cardiovascular preventive drug therapy, advantages and limitations of the current paradigm | |||
Heribert SCHUNKERT, Lübeck, GER [Presentation] | |||
The impact of recent clinical trials on the future of CVD assessment and risk management Transition to “risk score guided” strategies |
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Wolfgang KOENING, Ulm, GER [Presentation] | |||
Clinical utility of biomarkers and bioimaging as tools to identify patients who need drug therapy | |||
Matthias LORENZ, Frankfurt, GER | |||
Combined lipid lowering and blood pressure lowering in high risk patients. Rationale and design of the HOPE-3 trial | |||
Eva LONN, Hamilton, CAN [Presentation] | |||
Risk scoring. Beyond Framingham | |||
Jay COHN, Minneapolis, USA | |||
18:30-19:15 | FOYER ORSAY NORD ROOM | ||
ESC WORKING GROUP ON PHARMACOLOGY AND DRUG THERAPY NUCLEUS BUSINESS MEETING | |||
Friday December 3rd, 2010 | ||
08:30-10:30 | SALON ORSAY SUD ROOM | |
EXPERT WORKSHOP DEVICE THERAPY FOR MILD TO MODERATE HEART FAILURE |
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Chairmen: John CLELAND, Hull, GBR - Jean Yves LE HEUZEY, Paris, FRA | ||
MADIT-CRT, RAFT and heart failure device trials. Accumulating evidence | ||
Jean ROULEAU, Montreal, CAN - [Presentation] | ||
CRT and ICD therapy: How early in the disease process? | ||
Johannes HOLZMEISTER, Zurich, SUI | ||
Debate: From trial to approval to guidelines and adoption. How device trials will stand the journey? | ||
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Panellists: William ABRAHAM, Columbus, USA - John CLELAND, Hull, GBR - Jay COHN, Minneapolis, USA Martin COWIE, London, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Mihai GHEORGHIADE, Chicago, USA Johannes HOLZMEISTER, Zurich, SUI - Henry KRUM, Melbourne, AUS - Jean-Yves LE HEUZEY, Paris, FRA Marc PFEFFER, Boston, USA - Frank RUSCHITZKA, Zurich, SUI - Aldo MAGGIONI, Firenze, ITA Franco NACCARELLA, Bologna, ITA - Willem REMME, Rhoon, NED - Bernd SCHUBERT, Boston Scientific, BEL Jean ROULEAU, Montreal, CAN - Luigi TAVAZZI, Cotignola, ITA - Alphons VINCENT, Medtronic, NED Malcolm ARNOLD, London, CAN - David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA |
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08:30-10h30 | SALON ORSAY NORD ROOM | |
11:00-12h30 | PLENARY SESSION | |
TRIALS OF NEW ANTI-DIABETIC DRUGS A SHIFT IN PARADIGM | ||
Chairmen: Angeles ALONSO, Madrid, ESP - William C. CUSHMAN, Memphis, USA | ||
The value of the surrogate glycemic control and HbA1 C, the usual endpoint on which approval of diabetes drugs is based is being strongly challenged. Mega and long duration trials are currently undertaken in type 2 diabetes. They may be required to obtain significant improvements in macrovascular outcomes. However, to date, no benefits on macrovascular outcomes have been demonstrated. Ultimately, as at least 50% of the complications associated with type 2 diabetes are microvascular in nature, it may be more appropriate to focus on microvascular outcomes. Also, targeting disease progression rather than events may be appropriate. Because of recently published CV safety issues with the new anti-diabetic agents, the FDA produced proscriptive industry guidelines requesting the evaluation of CV risk in all new anti-diabetic therapies. Such measures create ethical and economic challenges. What to expect from a new anti-diabetic drug? Endpoint related issues
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The metabolic memory of HbA1c, how useful as a surrogate ? | ||
Hens WEDEL, Gothenburg, SWE |
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Debate: Are the current megatrials addressing the unmet needs? | ||
Panellists: Eric ABADIE, Paris, FRA - Stefan AGEWALL [Presentation], Oslo, NOR - Angeles ALONSO, Madrid, ESP John CLELAND, Hull, GBR - Robert CODY, Merck, USA - William C. CUSHMAN, Memphis, USA Jeffrey FRIEDMAN, Boehringer INGELHEIM, GER - Nancy GELLER, Bethesda, USA David GORDON, Bethesda, USA - Yasser KHDER, Boehringer INGELHEIM, FRA - Wolfgang KOENIG, Ulm, GER Basil LEWIS, Haïfa, ISR - Giuseppe MANCIA, Monza, ITA - John McMURRAY, Glasgow, GBR - Eva LONN, Hamilton, CAN - Prem PAIS , Bangalore, IND - Alfonso PEREZ, Takeda, USA - Bertram PITT, Ann ARBOR, USA - Stuart POCOCK [Presentation], London, GBR - James REVKIN, Boehringer INGELHEIM, USA - Eberhardt RITZ, Heidelberg, GER - Yves ROSENBERG , Bethesda, USA - Luis RUILOPE, Madrid, ESP - Heribert SCHUNKERT, Lübeck, GER - Daryl SLEEP, Takeda, USA - Peter SLEIGHT, Oxford, GBR - Christian TORP - Pedersen , Copenhagen, DEN - Hans-Jürgen WOERLE, Boehringer INGELHEIM, GER Hens WEDEL, Gothenburg, SWE - Faiez ZANNAD, Nancy, FRA |
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11:00-12:30 | SALON ORSAY SUD ROOM | |
EXPERT WORKSHOP MANAGEMENT OF HEART FAILURE PATIENTS GUIDED BY REMOTE HEMODYNAMIC MONITORING IS THE CONCEPT PROVEN? |
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Chairmen: Martin COWIE, London, GBR - William ABRAHAM, Columbus, USA | ||
Why do we need telemonitoring solutions for the heart failure patient? | ||
Martin COWIE, London, GBR - [Presentation] | ||
What to monitor? Defining the right signals which would prompt action. A review of the existing monitoring devices. | ||
Haran BURRI, Geneva, SUI | ||
Who should deal with the telemonitoring information? Practical issues | ||
Carlos MORAIS, Amadora, POR - [Presentation] | ||
Criteria for trial validation of telemedicine devices for heart failure patients? Critical appraisal of recent and ongoing trials (COMPASS; DOT-HF; DECODE; PARTNERS-HF; PRECEDE-HF; SENSE-HF; TELE-HF) |
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David WHELLAN, Philadelphia, USA | ||
Debate: How to generate evidence? Designing telemonitoring trials | ||
Panellists: William ABRAHAM, Columbus, USA - Haran BURRI, Geneva, SUI - Martin COWIE, London, GBR Kenneth DICKSTEIN, Stavanger, NOR - Jay COHN, Minneapolis, USA - Lawrence FINE, Bethesda, USA Mihai GHEORGHIADE, Chicago, USA - Gerasimos FILIPATTOS, Athens, GRE - Henry KRUM, Melbourne, AUS Alice MASCETTE, Bethesda, USA - Aldo MAGGIONI, Firenze , ITA - Sandrine MASSET, Boston Scientific, BEL Carlos MORAIS, Amadora, POR - Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT, Ann ARBOR, USA - Willem REMME, Rhoon, NED - Frank RUSCHITZKA, Zurich, SUI - Bernd SCHUBERT, Boston Scientific, BEL Jean ROULEAU, Montreal, CAN - Luigi TAVAZZI, Cotignola, ITA - Alphons VINCENT, Medtronic, GER David WHELLAN, Philadelphia, USA - Faiez ZANNAD, Nancy, FRA |
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12:30-13:45 | FOYER ORSAY NORD ROOM | |
Meet and Eat with the Expert session SAFETY ISSUES RELATED TO SERUM POTASSIUM IN CARDIOVASCULAR TRIALS - FALLING FROM CHARY BDE TO SCYLLA? |
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Chairmen: Keld KJELDSEN, Copenhagen, DEN - Luis MIGUEL Ruilope , Madrid, ESP | ||
The pathophysiology of serum potassium in cardio-renal disease | ||
Eberhardt RITZ, Heidelberg, GER - [Presentation] | ||
Targets for serum potassium in hypertension and heart failure; Preventing and managing hyperkalemia | ||
Luis Miguel RUILOPE, Madrid, ESP [Presentation] | ||
Serum potassium and cardiorenal outcomes in cardiovascular clinical trials of RAAS therapy | ||
Faiez ZANNAD, Nancy, FRA - [Presentation] | ||
Opportunities to prevent/treat hyperkalemia with potassium-binders. Objectives and design of the PEARL-HF trial | ||
Bertram PITT, Ann ARBOR, USA | ||
12:30-13:45 | SALON ORSAY SUD ROOM | |
MEET AND EAT WITH THE EXPERTS SESSION CV PREVENTION: ONE DRUG, MULTIDRUGS OR POLYPILL? |
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Chairman: Eva LONN, Hamilton, CAN - Marc PFEFFER, Boston, USA | ||
Polypill and primary CV prevention. Indian Polycap Study (TIPS) | ||
Prem PAIS, Bangalore, IND - [Presentation] | ||
Polypill and secondary prevention: the FOCUS trial | ||
Felipe MARTINEZ, Cordoba, ARG - [Presentation] | ||
The Red Heart multidrug pill Indo European UMPIRE trial | ||
Simon THOM, London, GBR | ||
The Regulatory approach. Approvability issues of the polypill | ||
Angeles ALONSO, Madrid, ESP - [Presentation] | ||
14:00-16:00 | SALON ORSAY SUD ROOM | |
EXPERT STATISTICIANS AND TRIALISTS DISCUSS THE MAJOR TRIALS OF THE YEAR |
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Chairmen: Bertram PITT, Ann ARBOR, USA - Mohamed SOBHY, Alexandria, EGY | ||
Medicine deals with treatments that work often but not always, so treatment success must be based on probability. This unique session is meant to be educational and possibly controversial. Interpreting trial results requires a good understanding of statistics and trial methodology. Senior statisticians and clinical trialists debate their own views as well as tips and tricks for understanding the most recent trials of the year. Speaker: Stuart POCOCK, London, GBR - [Presentation] Discussant: Roxana MEHRAN, New York, USA |
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Panellists: Corine BERNAUD, AstraZeneca, BEL - Robert CODY, Merck, USA - Lawrence FINE, Bethesda, USA Nancy GELLER, Bethesda, USA - David GORDON, Bethesda, USA - Steen HUSTED, Arhus, DEN Yasser KHDER, Boehringer INGELHEIM, FRA - Eva LONN, Hamilton, CAN - Gerasimos FILIPATTOS, Athens, GRE Damien LOGEART, Paris, FRA - Josep MASIP, Barcelona, ESP - Marco METRA, Brescia, ITA Christian MÜELLER, Basel, SUI - Semir NOUIRA, Mahdia, TUN - Hani SABBAH, Detroit, USA - Alice MASCETTE, Bethesda, USA - Giuseppe MANCIA, Monza, ITA - Roxana MEHRAN, New York, USA - Atul PATHAK, Toulouse, FRA Marc PFEFFER, Boston, USA - Bertram PITT, Ann ARBOR, USA - Stuart POCOCK, London, GBR - Yves ROSENBERG, Bethesda, USA - Patrick ROSSIGNOL, Nancy, FRA - Victor SEREBRUANY, Towson, USA - Harry SHI, Pfizer, USA Mohamed SOBHY, Alexandria, EGY - Christian TORP PEDERSEN, Copenhagen, DEN - Hans WEDEL, Gothenburg, SWE - Andrew ZALEWSKI, Novartis, USA - Faiez ZANNAD, Nancy, FRA. |
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14:00-16:00 | SALON ORSAY NORD ROOM | |
PLENARY SESSION HEART RATE REDUCTION WITH IVABRADINE: FROM CLINICAL TRIALS TO CLINICAL PRACTICE |
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Chairmen: Michael BÖHM, Homburg, GER - Faiez ZANNAD, Nancy, FRA | ||
Body of evidence of the importance of heart rate reduction | ||
Martin COWIE, London, GBR - [Presentation] | ||
Management of heart rate in CAD: lessons from the BEAUTIFUL study | ||
Jeffrey S. BORER, New York, USA [Presentation] | ||
Management of heart rate in HF: lessons from the SHIFT study | ||
Michael BÖHM, Homburg, GER [Presentation] | ||
Heart rate management in clinical practice with ivabradine | ||
Giuseppe ROSANO, Roma, ITA - [Presentation] | ||
Debate: The challenge of optimization of heart failure therapy. Is there a limit to polypharmacy? | ||
Panellists: Stefan AGEWALL, Oslo, NOR - Michael BÖHM, Homburg, GER - Jeffrey S. BORER , New York, USA Martin COWIE, London, GBR - Jay COHN, Minneapolis, USA - Mihai GHEORGHIADE, Chicago, USA Mona FIUZAT, Durham, USA - Wolfgang KOENIG, Ulm, GER - Henry KRUM, Melbourne, AUS - Guy LEREBOURS, Servier, FRA Felipe MARTINEZ, Cordoba, ARG - John McMURRAY, Glasgow, GBR - Willem REMME, Rhoon, NED Giuseppe ROSANO, Roma, ITA - Heribert SCHUNKERT, Lübeck, GER - Kurt STOSCHITZKY, Graz, AUT Luigi TAVAZZI, Cotignola, ITA - Faiez ZANNAD, Nancy, FRA |
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16:30-19:00 | SALON ORSAY SUD ROOM | |
EXPERT WORKSHOP METHODOLOGICAL, PRACTICAL AND REGULATORY FRAMEWORK FOR CONDUCTING AN ANTI-THROMBOTIC THERAPY OUTCOME TRIAL IN ATRIAL FIBRILLATION |
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Chairmen: Sidney GOLDSTEIN, Detroit, USA - Christian TORP-PEDERSEN, Copenhagen, DEN | ||
Rationale: Several new anti-thrombotic agents and interventional therapies have been subjected to or are being assessed in large mortality and morbidity atrial fibrillation trials. Several challenges and issues are related to designing, conducting and interpreting the results of an anti-thrombotic trial. Understanding these issues is critical for an optimal implementation of the results of these trials into daily clinical practice. |
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Objectives:
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Lectures: Limitations of warfarin anticoagulation and unmet needs in atrial fibrillation stroke prevention. |
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Gregory LIP, Birmingham, GBR - [Presentation] | ||
New anti-thrombotic agents versus Warfarin in Patients with Atrial Fibrillation. An update on recent and ongoing trials. | ||
Freek VERHEUGT, AMS, NED | ||
Debate: Defining the target population and reshaping the guidelines | ||
Dosing issues in thrombosis trials. e.g. Progression from Phase 2 to Phase 3 trials with new oral anti-thrombotic agents | ||
Discussant: Yasser KHDER, Boehringer Ingelheim, FRA - [Presentation] | ||
PROBE vs. Double Blind study designs in thrombosis trials | ||
Discussant: Gregory LIP, Birmingham, GBR - [Presentation] | ||
What is a clinically meaningful benefit? All cause vs cause specific events | ||
Discussant: Freek VERHEUGT, Amsterdam, NED - [Presentation] | ||
Panellists: Corine BERNAUD, AstraZeneca, BEL - Alain GAY, Bayer, FRA - Sidney GOLDSTEIN - Detroit, USA - Yasser KHDER, Boehringer INGELHEIM, FRA - Stuart KUPFER, Takeda, USA - Andrea LASLOP, Innsbruck, AUT- Gregory LIP, Birmingham, GBR - Basil LEWIS, Haïfa, ISR - Franco NACCARELLA, Bologna, ITA - Yves ROSENBERG, Bethesda, USA Ogun SAZOVA, AstraZeneca, BEL- Luigi TAVAZZI, Cotignola, ITA - Christian TORP-PEDERSEN, Copenhagen, DEN Freek VERGHEUGT, Amsterdam, NED - Lars WALLETIN, Uppsala, SWE - Hans-Jürgen WOERLE, Boehringer INGELHEIM, GER - Faiez ZANNAD, Nancy, FRA |
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16:30-18:30 | SALON ORSAY NORD ROOM | |
ALDOSTERONE RECEPTOR BLOCKERS ACROSS THE HEART FAILURE SPECTRUM | ||
Chairmen: John McMURRAY, Glasgow, GBR - Kenneth DICKSTEIN, Stavanger, NOR | ||
A historical perspective of evidence based therapy in heart failure | ||
Jay COHN, Minneapolis, USA | ||
EMPHASIS-HF : Extending the indication of eplerenone to mild heart failure | ||
Faiez ZANNAB, Nancy, FRA - [Presentation] | ||
Aldosterone receptor blockers across the heart failure spectrum. Practical issues and updating the guidelines - [Presentation] | ||
Henry KRUM, Melbourne, AUS | ||
Anti-aldosterone therapy. New drugs and new trials | ||
Bertram PITT, Ann Arbor, USA | ||
18:30-19:30 | Meeting with the steering committee |
Saturday December 4th, 2010 | ||
08:00-10:30 | SALON ORSAY NORD ROOM | |
11:00-12:30 | «How to» Workshop | |
HOW TO STOP A TRIAL PREMATURELY FOR EXCESS OF BENEFIT | ||
Chairmen: John McMURRAY, Glasgow, GBR - Stuart POCOCK, London, GBR | ||
Rationale: |
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08:30-10:30 | SALON ORSAY SUD ROOM | |
11:00-12:30 | EXPERT WORKSHOP | |
CARDIAC RESYNCHRONIZATION THERAPY BEYOND LBBB AND WIDE QRS | ||
Chairmen: Johannes HOLZMEISTER, Zurich, SUI - William ABRAHAM, Columbus, USA | ||
Rationale and design of the Echo-CRT trial | ||
Frank RUSCHITZKA, Zurich, SUI - [Presentation] | ||
Debate: From proof of concept to a large scale morbidity and mortality trial. Design challenges. Bearing results implementation in mind.
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Panellists: William ABRAHAM, Columbus, USA - Malcolm ARNOLD, London, GBR - John CLELAND, Hull, GBR Kenneth DICKSTEIN, Stavanger, NOR - Johannes HOLZMEISTER, Zurich, SUI - Henry KRUM, Melbourne, AUS Stuart POCOCK, London, GBR - Alphons VINCENT, Medtronic, GER - Frank RUSCHITZKA, Zurich, SUI Faiez ZANNAD, Nancy, FRA |
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09:00-10:30 | FOYER ORSAY NORD ROOM | |
11:00-12:30 | EXPERT WORKSHOP | |
MAXIMIZING THE BENEFITS FROM ANGIOTENSIN RECEPTOR ANTAGONISTS - ENHANCED POTENCY AND COMBINATION THERAPY |
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Chairmen: Angeles ALONSO, Madrid, ESP - Giuseppe MANCIA, Monza, ITA | ||
Are all angiotensin receptor blockers alike? Are maximized potency and ancillary effects clinically relevant? | ||
Luis RUILOPE, Madrid, ESP - [Presentation] | ||
How to cook a good combo recipe? What is the ideal diuretic to combine? | ||
Stuart KUPFER, Takeda, USA - [Presentation] | ||
Is combination therapy to become the rule? Insight from hypertension outcome trials and recent guidelines | ||
Giuseppe MANCIA, Monza, ITA - [Presentation] | ||
How to prove/claim added value conferred by ancillary properties? | ||
Angeles ALONSO, Madrid, ESP - [Presentation] | ||
How to prove/claim superiority of a new combo drug? | ||
William C. CUSHMAN, Memphis, USA - [Presentation] | ||
Debate: Approvability of new anti-hypertensive agents. | ||
Panellists: Angeles ALONSO, Madrid, SPA - William C. CUSHMAN, Memphis, USA - Stuart KUPFER, Takeda, USA Eva LONN, Hamilton, CAN - Giuseppe MANCIA, Monza, ITA - Alfonso PEREZ, Takeda, USA - Bertram PITT, Ann Arbor, USA Patrick ROSSIGNOL, Nancy, FRA - Vladimir POPOV, Moscow, RUS - Luis RUILOPE, Madrid, SPA - Darryl SLEEP, Takeda, USA - Faiez ZANNAD, Nancy, FRA |
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12:30-13:45 | SALON ORSAY NORD ROOM | |
PLENARY GUEST LECTURE CHALLENGING HYPOTHESES TO BE TESTED IN FUTURE TRIALS The CV Trialists «FORUM» |
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«fo•rum (fôrm, fr-) n. pl. fo•rums also fo•ra (fôr, fr)
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Clinical trials are humbling experiences. Drug discovery is not a linear process. Many drugs have failed to demonstrate the benefits that were expected from their pharmacological profile. Interestingly, many others have “apparently unexpected” benefits which were not originally predicted from their pharmacodynamic effects. Pleiotropic effects and off target effects have been sometime used to explain these non-linear findings. In this CVCT “Forum” session a tribune is given to an experienced trialist to present new “out of the box” challenging ideas that could be subjected to new trials. He should stand the criticisms of plebeian trialists, sceptical scientists and hard to convince sponsors. |
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Carte blanche to: Marc PFEFFER, Boston, USA - [Presentation] |
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Panellists: Kirkwood ADAMS, Chapel Hill, USA - Jeffrey S. BORER, New York, USA - Jay COHN, Minneapolis, USA Peter CLEMMENSEN, Copenhagen, DEN - John CLELAND, Hull, GBR - Kenneth DICKSTEIN, Stavanger, NOR Nancy GELLER, Bethesda, USA - Sidney GOLDSTEIN, Detroit, USA - Mihai GHEORGHIADE, Chicago, USA David GORDON, Bethesda, USA - Lawrence FINE, Bethesda, USA - Yasser KHDER, Boehringer INGELHEIM, FRA Wolfgang KOEING, Ulm, GER - Henry KRUM, Melbourne, AUS - Stuart KUPFER, Takeda, Chicago, USA Andrea LASLOP, Innsbruck, AUT - Eva LONN, Hamilton, CAN - Felipe MARTINEZ, Cordoba, ARG Alice MASCETTE, Bethesda, USA - Alexandre MEBAZAA, Paris, FRA - Roxana MEHRAN, New York, USA John McMURRAY, Glasgow, GBR - Marc PFEFFER , Boston, USA - Ileana PIÑA, Cleveland, USA - Betram PITT, Ann Arbor, USA - Stuart POCOCK, London, GBR - Vladimir POPOV, Moscow, RUS - Willem REMME, Rhoon, NED - James REVKIN, Boehringer INGELHEIM, USA - Yves ROSENBERG , Bethesda, USA - Harry SHI, Pfizer, USA Maarten SIMOONS , Rotterdam, NED - Bernard SWYNGHEDAUW, Paris, FRA - Christian TORP - PEDERSEN, Copenhagen, DEN John VINCENT, Pfizer, USA - Hans WEDEL, Gothenburg, SWE - David WHELLAN, Philadelphia, USA Faiez ZANNAD, Nancy, FRA |
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14:00-16:00 | SALON ORSAY SUD ROOM | |
16:30-18:00 | CVCT WORKSHOP STUDY DESIGN ISSUES IN THROMBOSIS TRIALS |
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Chairmen: Peter CLEMMENSEN, Copenhagen, DEN - Roxana MEHRAN, New York, USA | ||
There is no clear relationship between anti-coagulant or anti-platelet activity and clinical endpoint event rates. The single dose that is taken into phase III studies provides inadequate evidence of the optimal use of the drug. The FDA preferred approach is to take multiple doses into phase III and avoid over-valuing bleeding. Different definitions of bleeding across trials and variations in the way that bleeding data are captured make comparisons between studies difficult. Harmonization of collection and reporting of bleeding data in trials of anti-thrombotic drugs would be welcomed. ‘Net clinical benefit’ is not a substitute for benefit-risk. Time has an effect. One component can drive the results. Using more endpoints is not always better and results vary depending on the combination of endpoints. Combining safety and efficacy endpoints can make interpretation of study outcomes problematic. |
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Areas for experts’ discussion: | ||
Risk benefit issues in progressing to Phase III. Speaker: Sidney GOLDSTEIN, Detroit, USA - [Presentation] |
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Do surrogates and/or adaptive design help? Speaker: Roxana MEHRAN, New York, USA - [Presentation] Discussant: Sidney GOLDSTEIN, Detroit, USA |
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Combining efficacy and safety in composite endpoints Speaker: Andrea LASLOP, Innsbruck, AUT |
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PROBE vs Double Blind study design in antithrombotic trials Speaker: Hans WEDEL, Gothenburg, SWE Discussant: Christian TORP - PEDERSEN, Copenhagen, DEN - [Presentation] |
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Bleeding outcomes: Definitions and adjudication issues Speaker: Maarten SIMOONS, Rotterdam, NED - [Presentation] Discussant: Peter CLEMMENSEN, Copenhagen, DEN |
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Faculty: Peter CLEMMENSEN, Copenhagen, DEN - Alain GAY, Bayer, FRA - Sidney GOLDSTEIN, Detroit, USA Yasser KHDER, Boehringer INGELHEIM, FRA - Stuart KUPFER, Takeda, USA - Andrea LASLOP, Innsbruck, AUT John McMURRAY, Glasgow, GBR - Roxana MEHRAN, New York, USA - Prem PAIS, Bangalore, IND - James REVKIN, Boehringer INGELHEIM, USA - Yves ROSENBERG, Bethesda, USA - Maarten SIMOONS, Rotterdam, NED Daryl SLEEP, Takeda, USA - Mohamed SOBHY, Alexandria, EGY - Christian TORP - PEDERSEN, Copenhagen, DEN, Hans WEDEL, Gothenburg, SWE - Faiez ZANNAD, Nancy, FRA. |
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14:00-16:00 | SALON ORSAY NORD ROOM | |
16:30-18:00 | CVCT WORKSHOP ACUTE HEART FAILURE TRIALS. HOW TO OVERCOME ENROLLMENT CHALLENGES |
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Chairmen: Mihai GHEORGHIADE, Chicago, USA - Faiez ZANNAD, Nancy, FRA | ||
Rationale: | ||
A fundamental problem in performing heart failure (HF) trials relates to multiple issues including:
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Objectives: | ||
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Programme (each topic will be followed by a 30 min discussion): Introduction: |
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Experience with recent trials in acute and chronic HF. Enrollment challenges and regional differences | ||
Mihai GHEORGHIADE, Chicago, USA - [Presentation] | ||
Lessons from the largest Acute Heart Failure Trials: ASCEND HF | ||
Chris O’CONNOR, Durham, USA | ||
How to set up a HF research centre that can enroll “real life” patients in all HF research areas | ||
Experience from Central Europe | ||
Alexandre MEBAZAA, Paris, FRA - [Presentation] | ||
Experience from Western Europe | ||
Marco METRA, Brescia, ITA | ||
Experience from the USA | ||
Mihai GHEORGHIADE, Chicago, USA | ||
Experience from South America | ||
Felipe MARTINEZ, Cordoba, ARG | ||
Experience from Africa | ||
Semir NOUIRA, Mahdia, TUN - [Presentation] | ||
Experience in Asia | ||
Prem PAIS, Bangalore, IND - [Presentation] | ||
Organizational aspects of better HF studies: what should the common mechanism be? The «nuts and bolts» of regulatory packages and contracts |
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Gad COTTER, Durham, USA - [Presentation] | ||
Understanding the heterogeneity of the syndrome: The need for a global registry of HF patients | ||
Faiez ZANNAD, Nancy, FRA | ||
How can we do better studies? | ||
Lothar ROESSIG, Bayer, GER | ||
Faiez ZANNAD, Nancy, FRA | ||
Panel discussion: Opportunities for training and setting a durable network of HF trials investigators. | ||
Lothar ROESSIG, Bayer, GER | ||
Panellists: William ABRAHAM, Columbus, USA - Kirkwood ADAMS, Chapel Hill, USA Alain COHEN SOLAL, Paris, FRA - Jay COHN, Minneapolis, USA - Gad COTTER, Durham, USA Martin COWIE, London, GBR - Kenneth DICKSTEIN, Stavanger, NOR - Gerasimos FILIPPATOS, Athens, GRE Mihai GHEORGHIADE, Chicago, USA - Mona FIUZAT, Durham, USA - Ewa JANKOWSKA, Wroclaw, POL Aldo MAGGIONI, Firenze, ITA - Josep MASIP, Barcelona, ESP - Felipe MARTINEZ, Cordoba, ARG Alexandre MEBAZAA [Presentation] , Paris, FRA - Marco METRA, Brescia, ITA - Christian MÜELLER, Basel, SUI Semir NOUIRA, Mahdia, TUN - Chris O’CONNOR, Durham, USA - Prem PAIS, Bangalore, IND Marc PFEFFER, Boston, USA - Ileana PIÑA, Cleveland, USA - Bertram PITT, Ann ARBOR, USA Willem REMME, Rhoon, NED - Lothar ROESSIG, Bayer, GER - Frank RUSCHITZKA, Zurich, SUI Hani SABBAH, Detroit, USA - Norman STOCKBRIDGE, Rockville, USA - Luigi TAVAZZI, Cotignola, ITA Andrew ZALEWSKI, Novartis, USA - Faiez ZANNAD, Nancy, FRA. |