CVCT 9th Global Cardiovascular Clinical Trialists Forum • Paris 2012

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 2 - Friday November 30, 2012 : ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALS Facilitating the discovery of effective therapies Chairpersons: Jagat NARULA, New York, USA - Ahmed

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick

MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick

MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick

MODIGLIANI Debate Session 5 - Saturday December 1st, 2012 NOVEL DIURETIC STRATEGIES IN HEART FAILURE Chairpersons: Keld KJELDSEN, Copenhagen, DEN - Gian Paolo ROSSI, Padua, ITA Webcast: Patrick

Will new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C lesser than 70mg/dl)?

MODIGLIANI Debate Session 4 - Saturday December 1st, 2012: HEART FAILURE REMOTE MONITORING TRIALS Chairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USA Webcast: Daniela DOBRE, Nancy,

MODIGLIANI Debate Session 4 - Saturday December 1st, 2012: HEART FAILURE REMOTE MONITORING TRIALS Chairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USA Webcast: Daniela DOBRE, Nancy,

Will new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C lesser than 70mg/dl)?

Will new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C lesser than 70mg/dl)?

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012: HEART FAILURE TRIALISTS WORKSHOP LEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALS Chairpersons: Alexandre

Will new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C lesser than 70mg/dl)?

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012 THE DEVICE THERAPY TRIALISTS WORKSHOP Chairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USA Webcast: Tariq AHMAD,

MODIGLIANI Workshop 2 - Friday November 30, 2012 : ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALS Facilitating the discovery of effective therapies Chairpersons: Jagat NARULA, New York, USA - Ahmed

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

MODIGLIANI Workshop 1 - Friday November 30, 2012 : THE THROMBOSIS TRIALISTS WORKSHOP DOSE AND TARGET PATIENT POPULATIONS ISSUES Chairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN,

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries • NICE Speaker: Suzanna HARDMAN, London, GBR • German CHF registry:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : National guideline implementation and national registries. • NICE Speaker: Suzanna HARDMAN, London, GBR • German CHF registry:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : conclusion George BAKRIS, Chicago, USA - Sverre E. KJELDSEN, Oslo, NOR Abstract : conclusion L’auteur n’a pas transmis de conflit

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate : What relevant endpoints in autonomic nerve modulation therapy trials? What kind/level of evidence? Targets to meet for

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Autonomic modulation therapy for heart failure: Preclinical data and ongoing trials Speaker: Faiez ZANNAD, Nancy, FRA Discussant:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Barostim: Experience so far and future developments Speaker: Hermann HALLER, Hannover, GER Discussant: Nadim YARED, CVRx, USA

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure? Speaker: Felix MAHFOUD, Homburg, GER Discussant

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Resistant hypertension trials: Can renal denervation therapy lower blood pressure? Speaker: Felix MAHFOUD, Homburg, GER Discussant

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Debate led by Journal Editors: There are too many studies and the quality is variable. Should there be a position statement

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Biomarker guided-therapy: Are there other endpoints besides mortality that matter? Selecting the best outcome measures Speaker:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate : Best statistical methods for evaluating the merits of a novel marker (debates). Speaker: Stefan BLANKENBERG, Hamburg, GER

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Best statistical methods for evaluating the merits of a novel marker Speaker: Stefan BLANKENBERG, Hamburg, GER Discussant: Nancy

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Best statistical methods for evaluating the merits of a novel marker Speaker: Stefan BLANKENBERG, Hamburg, GER Discussant: Nancy

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : How should diagnostic/prognostic markers be studied? Speaker: Jim JANUZZI, Boston, USA Discussant: James SNIDER, Critical

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : How should diagnostic/prognostic markers be studied? Speaker: Jim JANUZZI, Boston, USA Discussant: James SNIDER, Critical

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints Speaker: Joseph LOSCALZO, Boston, USA, Circulation Discussant: Rita REDBERG, San Francisco, USA, Arch

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints Speaker: John JARCHO, Boston, USA, NEJM Discussant: Rita REDBERG, San Francisco, USA, Arch Intern Med

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : The role of biomarkers Speaker: Stefan BLANKENBERG, Hamburg, GER Abstract : The role of biomarkers L’auteur n’a pas transmis de

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : debate Omics research and system biology. Keys for future personalized medicine How future trials may help optimizing benefit-to

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Omics research and system biology. Keys for future personalized medicine How future trials may help optimizing benefit-to-risk

How future trials may help optimizing benefit-to-risk ratio. The role of specialist scientific organizations. ISCP: Speaker: Felipe MARTINEZ, Cordoba, ARG CVCT: Speaker: Faiez ZANNAD, Nancy, FRA ESC

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Is it always safe to believe in class effect: Spironolactone vs. eplerenone differences and clinical relevance? Speaker: Bertram

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Compound vs. class effect. Drug class recommendations in guidelinesCanadian, Australian CHF guideline and 2010 NICE guideline.

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Expected implications on heart failure epidemiology. Speaker: Justin EZEKOWITZ, Edmonton, CAN Abstract : Expected implications on

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Impact of major clinical trials on ESC Chronic Heart Failure 2012 guidelines. Game changer trials: EMPHASIS-HF, SHIFT, Devices…

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Interpretation and approvability issues. Industry viewpoint: Paul AUDHYA, Reata, USA Regulatory viewpoint: Pieter DE GRAEF, EMEA, NED Abstract

Title : Cardiovascular Clinical Trialists (CVCT) Forum – RAAS inhibitors and Mineralocorticoid receptor antagonists (FOSIDIAL, ALCHEMIST) Speaker: Patrick ROSSIGNOL, Nancy, FRA Abstract : RAAS

Title : Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients (debates). Speakers: Chris MIX, Amgen, USA - David WHEELER, London, GBR

Title : Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients Speakers: Chris MIX, Amgen, USA - David WHEELER, London, GBR Discussant:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients Speakers: Chris MIX, Amgen, USA - David WHEELER, London, GBR Discussant:

Title: Cardiovascular Clinical Trialists (CVCT) Forum – EVOLVE: A major cardiovascular outcomes trial in hemodialysis patients. Speakers: Chris MIX, Amgen, USA - David WHEELER, London, GBR Discussant:

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Lipid lowering agents. Now, we have an option! (SHARP, 4D, AURORA) Speaker: Colin BAIGENT, Oxford, GBR Abstract : Lipid lowering agents. Now,

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Save life and save cost with ivabradine. Speaker: Martin COWIE, London, GBR Abstract :  Clinical evidence suggests that an

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : SHIfTing evidence in heart failure management. Speaker: Jeffrey BORER, New York, USA Abstract : SHIFT (Systolic Heart failure

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : on top of or vs. Metformin? The issue of background therapy and comparator Speaker: Michel

Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance (debates)

Title :Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance Speaker: Marc PFEFFER, Boston, USA Discussant: Stuart

Title: Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Non-inferiority, superiority, or both? Operationalizing the FDA guidance Speaker: Marc PFEFFER, Boston, USA Discussant: Stuart

Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy (debates).

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : What else than glucose control? Lipids, BP, Weight, Kidney Speaker: Denise BONDS, NHLBI, USA Abstract : What else than glucose

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Study drug and background therapy : Insulin in type 2 diabetes: bad guy or good guy? Speaker: Michel MARRE, Paris, FRA Abstract :

Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful? (debates)

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful? Speaker: Wolfgang KOENIG, Ulm, GER Discussant:

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful? Speaker: Wolfgang KOENIG, Ulm, GER Discussant:

Title : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries (debates). Prem PAIS, Bangalore, IND Speaker: Mohamed SOBHY, Alexandria, EGY Abstract :

Title : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries Speaker: Mohamed SOBHY, Alexandria, EGY Abstract : Diabetes is one of the major public health

Title : Globalization of Diabetes trials: Epidemiology of diabetes in the Middle East and Asian countries Speaker: Prem PAIS, Bangalore, IND Abstract : India has a high prevalence of type 2 diabetes