Stefan AGEWALL, Stockholm - SWE – Angeles ALONSO, Madrid - SPA – Céline SERIO, Sophia Antipolis - FRA
Wiek VAN GILST, Groningen - NED – Finn GUSTAFSSON, Copenhagen - DEN
Keld KJELDSEN, Copenhagen - DEN – Luis RUILOPE, Madrid - SPA – Kurt STOSCHITZKY, Graz - AUT
Faiez ZANNAD, Nancy - FRA

Format: Short presentations (no lecturing) in order to set the stage for a large expert panel discussion

• What are the unmet needs?
• The clinician point of view: Alexandre MEBAZAA, Paris - FRA

• Industry point of view
• Hemodynamic monitoring: Frederic MICHARD, Edwards Lifesciences, Nyon - SWI
• Trade off in heart failure: why clinical trial on ADHF should focus on quality of life : Piero POLLESELLO, Orion Pharma, Espoo - FIN [presentation]

• What are the optimal endpoints?
• The emergentist point of view: Patrick RAY, Paris - FRA [presentation]
• The intensivist (ICU/CCU) point of view: Birhan Mehmet YILMAZ, Sivas - TUR [presentation]
• The cardiac surgeon point of view: Antonis PITSIS, Tessaloniki - GRE [presentation]

Panellists: Xavier BAERMANN, Argenteuil - FRA – Abdel BELLOU, Rennes - FRA
Enrique CASALINO, Paris - FRA – Jean CASSAGNES, Clermont Ferrand - FRA – Bernard CHOLLEY, Paris - FRA
Alain COHEN SOLAL, Paris - FRA – Jean Emmanuel de La COUSSAYE, Nimes - FRA
Nicolas DEYE, Paris - FRA – Pierre GIBELIN, Nice - FRA – Corinna HEINISCH, Bâle - SWI
Guillaume JONDEAU, Paris - FRA – Said LARIBI, Paris - FRA – Alexandre MEBAZAA, Paris - FRA
Frederic MICHARD, Edwards Lifesciences - SWI – Atul PATHAK, Toulouse - FRA
Antonis PITSIS, Tessaloniki - GRE – Patrick PLAISANCE, Paris - FRA
Piero POLLESELLO, Orion Pharma, Espoo - FIN – Patrick RAY, Paris - FRA
Guillaume Der SAHAKIAN, Paris - FRA – Jane-Lise SAMUEL, Paris - FRA – Franck SIBELLAS, Lyon - FRA
Eric WIEL, Lille - FRA – Birhan Mehmet YILMAZ, Sivas TUR – Faiez ZANNAD, Nancy - FRA

• Objectives:
• Discussing the opportunities and challenges of an optimal implementation of the results of the device trials
• Discussing the strengths and limitations of the device trials in heart failure

• Patient population and outcome issues: What is the clinical significance of the results of MADIT-CRT
  Chairman: Karl SWEDBERG, Göteborg - SWE
• What are the patients eligible for CRT-D? How to estimate the size of the eligible population?
  Speaker: Mihai GHEORGHIADE, Chicago - USA [presentation]
  Discussant: Aldo MAGGIONI, Florence - ITA[presentation]
• The relative contribution of preventing death and preventing HF hospitalization
  Speaker: Frederic ANSELME, Rouen - FRA [presentation]
  Discussant: Faiez ZANNAD, Nancy - FRA
• The Clinician point of view: Generalizability of the results of recent trials (MADIT-CRT)
  Gunter BREITHARDT, Münster - GER [presentation]

• Mechanistic issues: How does CRT-D work for the prevention of HF hospitalization?
  Chairman: Daniel GRAS, Nantes - FRA
• Consistency within the trial subgroups, consistency with other CRT and ICD trials
  Cecilia LINDE, Stockhlom - SWE
• Mechanistic plausibility. Insight from pathophysiology – importance of improvement of LV function across all trials
  Mark ESTES, Boston - USA [presentation]

• Registerability and implementation issues
  Chairman: Faiez ZANNAD, Nancy - FRA
• Is “Prevention of HF events” in mild HF patients with large QRS and low EF an approvable new indication for CRT-D?
  Bernd LEMKE, Lüdenscheid - GER[presentation]
  Discussant: Daniel GRAS, Nantes - FRA[presentation]
• Updating the guidelines and overcoming implementation issues/barriers
  Karl SWEDBERG, Göteborg - SWE [presentation]

Panellists: Kirkwood ADAMS, Chapell Hill - USA – Angeles ALONSO, Madrid - SPA
Frederic ANSELME, Rouen - FRA – Olivier BARTHEZ, Dijon - FRA – Gunter BREITHARDT, Münster - GER
Mark ESTES, Boston, USA – Mihai GHEORGHIADE, Chicago - USA – Daniel GRAS, Nantes - FRA
Jean-Yves LE HEUZEY, Paris - FRA – Bernd LEMKE, Lüdenscheid - GER – Cecilia LINDE, Stockholm - SWE
Aldo MAGGIONI, Florence - ITA – Edmond ROLAND, EMEA, Paris - FRA – Karl SWEDBERG, Götborg - SWE
Faiez ZANNAD, Nancy - FRA

• The young CVCT initiative: Time to rejuvenate CV clinical trialists
  Bertram PITT, Ann Arbor - USA [presentation]
• Maximizing scientific knowledge from randomized clinical trials data. Opportunities for young CVCT fellows
  Gilles DAGENAIS, Quebec - CAN [presentation]
• How to teach trial methodology to young clinicians?
  Eric VICAUT, Paris - FRA [presentation]
• Responsibilities, role and functioning of trial committees (Steering committee, DSMC, Event committee)
  Sidney GOLDSTEIN, Detroit - USA [presentation]

• How evidence based is the current risk stratification guided CV preventive drug therapy?
  Luis RUILOPE, Madrid - SPA[presentation]
• The challenge of designing a biomarker trial
  Faiez ZANNAD, Nancy - FRA[presentation]
• Biomarker guided therapy: Trial design and interpretation issues
  Kirkwood ADAMS, Chapell Hill - USA

Debate: Design of Biomarkers for CV trials
The industry viewpoint.
Ursula-Henrike WIENHUES-THELEN, Roche Diagnostics - GER

The regulator viewpoint
Bruno FLAMION, European Medicines Agency - EMEA, Brussels - BEL[presentation]

Panellists: Kirkwood ADAMS, Chapell Hill - USA – Enrico AGABATI-ROSEI, Brescia - ITA
Alain COHEN SOLAL, Paris - FRA – Finn GUSTAFSSON, Copenhagen - DEN – Wim HOUDIJK, Biomérieux - FRA
Patrick JOURDAIN, Paris - FRA – Alexandre MEBAZAA, Paris - FRA
Patrick ROSSIGNOL, Nancy - FRA – Luis RUILOPE, Madrid - SPA – Nancy SEYMOUR, Inverness, Biosite - USA
Dominique SURUN, Aterovax - FRA – Wiek VAN GILST, Groningen - NED
Ursula-Henrike WIENHUES-THELEN, Roche Diagnostics - GER

• Aldosterone: a culprit hormone in cardiovascular disease
  Johann BAUERSACHS, Würzburg - GER
• Which is to blame? Is it aldosterone or mineralocorticoid receptor activation?
  Frederic JAISSER, Paris - FRA
• Pharmacology of agents interfering with the aldosterone pathways
  Michel AZIZI, Paris - FRA
• Update on aldosterone trials
  Faiez ZANNAD, Nancy - FRA[presentation]
• Practical use of agents acting on the aldosterone system.
  Where to fit into the RAAS drug armamentarium?
  Bertram PITT, Ann Arbor - USA[presentation]

• Overview of international cardiovascular clinical trials and current regulatory requirements for clinical trials in Russia and Ukraine
  Vladimir POPOV, Moscow - RUS[presentation]
• Middle East and the Arab world, emerging to CardioVacular trials. Cultural, organisational and regulatory aspects
  Mohamed SOBHY, Alexandria - EGY
• Regional Risk Factors and Cardiovascular trials: no influence or high impact?
  Felipe MARTINEZ, Cordoba - ARG

• Introduction and overview: Why does sleep disordered breathing deserve the cardiologist’s attention?
  Christiane ANGERMANN, Würzburg - GER
• Future clinical evidence needs? Design of the SERVE-HF protocol
  Luc HITTINGER, Paris - FRA[presentation]
• How to screen and manage patients with SDB in the clinical cardiology routine?
  Olaf OLDENBURG, Bad Oeynhausen - GER

• Cardiovascular clinical trials under the EU Research Framework Programmes? A good start or a missed opportunity?
  Faiez ZANNAD, Nancy - FRA[presentation]
• National Heart Lung and Blood Institute cardiovascular drug trials - future directions?
  Michael DOMANSKI, Bethesda - USA

Debate: Going global. Is an NHLBI-EU joint cardiovascular trial initiative at all feasible?

Panellists: Kirkwood ADAMS, Chapell Hill - USA – Enrico AGABATI-ROSEI, Brescia - ITA
Christian BOITARD, Inserm, Paris - FRA – Gérard BRÉART, Paris - FRA
Virginija DAMBRAUSKAITE, EU, Brussels - BEL – Jacques DESMOTES, ECRIN, Bordeaux - FRA
Michael DOMANSKI, NHLBI, Bethesda - USA – Nancy GELLER, NHLBI, Bethesda - USA
Mihai GHEORGHIADE, Chicago - USA – David GORDON, NHLBI, Bethesda - USA
Michael LAUER, NHLBI, Bethesda, USA – Alexandre MEBAZAA, Paris - FRA
Bertram PITT, Ann Arbor - USA – Philippe G. STEG, Paris - FRA – Faiez ZANNAD, Nancy - FRA

• Will new drugs and new trials shift the rate vs. rhythm control paradigm (Dronedarone, Vernakalant)?
  Gunter BREITHARDT, Münster - GER[presentation]
• New anti-thrombotic trials in atrial fibrillation (RE-LY) and possible consequence on anti-thrombotic strategies
  Gregory LIP, Birmingham - GBR
• Ablation in atrial fibrillation: Reassessing the evidence
  Christian DE CHILLOU - Nancy, FRA[presentation]

Debate: Revisiting the rate vs. rhythm control debate in the light of the new pharmacological environment.

Panellists: Christian DE CHILLOU, Nancy - FRA – Angeles ALONSO, Madrid - SPA – Dan ATAR, Oslo - NOR
Gunter BREITHARDT, Münster - GER – Alain COHEN SOLAL, Paris - FRA
Finn GUSTAFSSON, Copenhagen - DEN – Patrick JOURDAIN, Paris - FRA – Keld KJELDSEN, Copenhagen - DEN
Gregory LIP, Birmingham - GBR – Aldo MAGGIONI, Florence - ITA
Kurt STOSCHITZKY, Graz - AUT – Karl SWEDBERG, Göteborg - SWE – Wiek VAN GILST, Groningen - NED
Faiez ZANNAD, Nancy - FRA

• Clinical significance of lowering central BP and arterial stiffness
  Athanas BENETOS, Nancy - FRA[presentation]
• Central BP and arterial stiffness as clinical endpoints in large scale trials.
  Metrological and methodological issues
  Stéphane LAURENT, Paris - FRA
• Currently available drugs and new agents that decrease central BP and arterial stiffness.
  Insight from recent trials
  Luc VAN BORTEL, Ghent - BEL

Panellists: Enrico AGABATI-ROSEI, Brescia - ITA – Michel AZIZI, Paris - FRA
Athanas BENETOS, Nancy - FRA – Luc VAN BORTEL, Ghent - BEL – Alain COHEN SOLAL, Paris - FRA
Finn GUSTAFSSON, Copenhagen - DEN – Stéphane LAURENT - Paris - FRA – Atul PATHAK, Toulouse - FRA
Bertram PITT, Ann Arbor - USA – Patrick ROSSIGNOL, Nancy - FRA – Luis RUILOPE, Madrid - SPA
Michel SAFAR, Paris - FRA – Wiek VAN GILST, Groningen - NED – Charalambos VLACHOPOULOS, Athens - GRE
Ursula-Henrike WIENHUES-THELEN, Roche Diagnostics - GER

• Introduction
  Ake HJALMARSON, Göteborg - SWE
• Heart rate reduction in clinical practice
  Ake HJALMARSON, Göteborg - SWE
• New results with Ivabradine
  Jeffrey BORER, New York - USA
• Coronary artery disease management: A step further with ivabradine
  Philippe G. STEG, Paris - FRA

• The pharmacology of modern anti-thrombotic drugs: how to maximize the benefit-to-bleed risk ratio?
  Tabassome SIMON, Paris - FRA
• Resistance to antiplatelet agents: biological fantasy or clinical reality?
  Gilles MONTALESCOT, Paris - FRA
• How the results of the most recent trials will change the anti-thrombotic strategy in acute coronary syndromes?
  Nicolas DANCHIN, Paris - FRA[presentation]
• Post acute coronary syndromes. Risk and management of anti-thrombotic therapy in the ambulatory patient
  Philippe G. STEG, Paris - FRA

Debate: unclot with little bleed. Unravelling the Gordian knot

Panellists: Dan ATAR, Oslo - NOR – Nicolas DANCHIN, Paris - FRA
Efthymios DELIARGYRIS, Athens - GRE – Pascale GAUSSEM, Paris - FRA – Antoine LAFONT, Paris, FRA
Gregory LIP, Birmingham - GBR – Gilles MONTALESCOT, Paris - FRA – Bertram PITT, Ann Arbor - USA
Stuart POCOCK, London - GBR – Tabassome SIMON, Paris - FRA – Philippe G. STEG, Paris - FRA
Faiez ZANNAD, Nancy - FRA

• Cardiovascular outcomes in chronic kidney disease, Rationale for future clinical trials
  Faiez ZANNAD, Nancy - FRA[presentation]
• Cardiovascular protection trials in end stage renal disease
  Bengt FELLSTROM, Uppsala - SWE
• Clinical trials targeting renal protection in heart failure and cardiovascular disease
  Marco METRA, Brescia - ITA[presentation]

Debate: What endpoints for a renoprotective agent in cardiovascular disease?

Panellists: Kirkwood ADAMS, Chapell Hill - USA – Stefan AGEWALL, Stockholm - SWE – Angeles ALONSO, Madrid - SPA
Bengt FELLSTROM, Uppsala SWE – Mihai GHEORGHIADE, Chicago - USA – Felipe MARTINEZ, Cordoba - ARG
Alexandre MEBAZAA, Paris - FRA – Marco METRA, Brescia - ITA – Patrick ROSSIGNOL, Nancy - FRA
Wiek VAN GILST, Groningen - NED – Faiez ZANNAD, Nancy - FRA

• Selecting the appropriate design
• Positive control, placebo-controlled trials vs. non inferiority head-to-head comparative trials. Which way to go?
  Speaker: Stuart POCOCK, London - GBR [presentation]
  Discussant: Yasser KHDER, Boehringer Ingelheim, Paris - FRA [presentation]
• Adaptive design. Strengths and limitation
  Speaker: Sidney GOLDSTEIN, Detroit - USA [presentation]
  Discussant: Michael DOMANSKI, Bethesda - USA
• Defining the appropriate patient population: ACS, AMI, STEMI/NSTEMI: terminology and definition matters
  Speaker: David MORROW, Boston - USA
  Discussant: Marteen SIMOONS, Rotterdam - NED
• Study drug and comparator drug related issues: Clinical and Regulatory challenges
• What is the optimal “reference” comparator?
  Speaker: Gregory LIP, Birmingham - GBR
• Timing of randomisation/dosing
  Speaker: Philippe G. STEG, Paris - FRA
  Discussant: Nicolas DANCHIN, Paris - FRA [presentation]
• Endpoint definition
• Time to first event vs. cumulative events
  Speaker: Christian TORP-PEDERSEN, Copenhagen - DEN [presentation]
  Discussant: Aldo MAGGIONI, Florence - ITA
• Composite events
  Speaker: John WARREN, London - GBR
  Discussant: Edmond ROLAND, Paris - FRA [presentation]
• Balancing benefit vs. risk
  Speaker: Edmond ROLAND, Paris - FRA [presentation]
  Discussant: Gregory LIP, Birmingham - GBR
• Interpretation issues
• Statistically significant vs. clinically meaningful results? A Statistical Interpretation of Recent Trials
  Speaker: Stuart POCOCK, London - GBR [presentation]

Faculty members Academy: Michael ANGIOI, Nancy - FRA – Vidal BENATAR, Saint-Cloud - FRA
Laurent BONELLO, Marseille - FRA – Jeffrey BORER, New York - USA – Jean CASSAGNES, Clermond-Ferrand - FRA
Gilles DAGENAIS, Quebec - CAN – Nicolas DANCHIN, Paris - FRA – Efthymios DELIARGYRIS, Athens - GRE
Gregory DUCROCQ, Paris FRA – Sidney GOLDSTEIN, Detroit - USA – Antoine LAFONT, Paris - FRA
Gilles LEMESLE, Lille - FRA – Gregory LIP, Birmingham - GBR – Aldo MAGGIONI, Florence - ITA
David MORROW, Boston - USA – Bertram PITT, Ann Arbor - USA – Stuart POCOCK, London - GBR
Tabassome SIMON, Paris - FRA – Marteen SIMOONS, Rotterdam - NED – Philippe G.STEG, Paris - FRA
Christian TORP-PEDERSEN, Copenhagen - DEN – Eric VICAUT, Paris - FRA – John WARREN, London - GBR
Faiez ZANNAD, Nancy - FRA

Faculty members NHLBI (NIH): Michael DOMANSKI, Bethesda - USA – Nancy GELLER, Bethesda - USA
David GORDON, Bethesda - USA

Faculty members EMEA / AFSSAPS: Eric ABADIE, Paris - FRA – Angeles ALONSO, Madrid - SPA
Fernando DE ANDRES, Trelles - ESP – Mira PAVLOVIC, Paris - FRA – Edmond ROLAND, Paris - FRA

Faculty members Industry: Maria-Niki AIGYPTIADOU, Daiichi-Sankyo - GER
Gunnar BRANDRUP, AstraZeneca - SWE – Yasser KHDER, Boehringer Ingelheim - FRA
Stuart KUPFER, Takeda - USA – Guy LEREBOURS, Servier - FRA – Hubert POULEUR, Pfizer - USA
James REVKIN, Boehringer Ingelheim - USA – Magali SARTRAL, Eli-Lilly - FRA

• 1. Data access
• 1.1. Data Cleaning issues
  Speaker: Jorgen SELDRUP, Quintiles - FRA[presentation]
  Discussant: Robert CODY, Merck - USA
• 1.2. Adjudicating issues
  Speaker: Aldo MAGGIONI, Florence - ITA [presentation]
  Discussant: Gilles DAGENAIS, Quebec - CAN [presentation]
• 1.3. Unblinding issues
  Speaker: Nancy GELLER, Bethesda - USA [presentation]
  Discussant: Phlippe G. STEG, Paris - FRA
• 2. Stopping rules in adaptive design trials
• 2.1. Methodological issues
  Speaker: Stuart POCOCK, London - GBR [presentation]
  Discussant: Michael DOMANSKI, Bethesda - USA
• 2.2. Ethical issues
  Speaker: Sidney GOLDSTEIN, Detroit - USA [presentation]
  Discussant: David GORDON, Bethesda - USA [presentation]
• 2.3. Regulatory issue
  Speaker: Amin KADI, MFF, Paris - FRA
  Discussant: John WARREN, London - GBR

Faculty members Academy: Kirkwood ADAMS, Chapell Hill - USA – Jeffrey BORER, New York - USA
Jan CARLSEN, Lyngby - DEN – Gilles DAGENAIS, Quebec - CAN - Nicolas DANCHIN, Paris - FRA
Virginija DAMBRAUSKAITE, EU, Brussels - BEL – Jacques DESMOTES, ECRIN, Bordeaux - FRA
Bengt FELLSTROM, Uppsala - SWE – Mihai GHEORGHIADE, Chicago - USA
Sidney GOLDSTEIN, Detroit - USA – Luc HITTINGER, Paris - FRA – Guillaume JONDEAU, Paris, FRA
Stéphane LAURENT, Paris, FRA – Aldo MAGGIONI, Florence - ITA – Gilles MONTALESCOT, Paris - FRA
Bertram PITT, Ann Arbor - USA – Stuart POCOCK, London - GBR – Phlippe G. STEG, Paris - FRA
Marteen SIMOONS, Rotterdam - NED – Chris TORP PEDERSEN, Copenhagen - DEN
Eric VICAUT, Paris - FRA – John WARREN, London - GBR – Faiez ZANNAD, Nancy - FRA

Faculty members: NHLBI (NIH): Michael DOMANSKI, Bethesda - USA
Nancy GELLER, Bethesda - USA –David GORDON, Bethesda - USA

Faculty members Industry and CROs: Michel ABITEBOUL, Quintiles - FRA – Bertrand BEAU, Parexel - FRA
Robert CODY, Merck - USA – Amin KADI, MFF - FRA – Yasser KHDER, Boehringer Ingelheim - FRA
Stuart KUPFER, Takeda, USA – Michel LEVY, ADDS - FRA – Vladimir POPOV, Esmar - RUS
Hubert POULEUR, Pfizer - USA – James REVKIN, Boehringer Ingelheim - USA – Jorgen SELDRUP, Quintiles - FRA

Faculty members EMEA / AFSSAPS: Eric ABADIE, Paris - FRA – Angeles ALONSO, Madrid - SPA
Fernando De ANDRES, Trelles - SPA