THURSDAY, NOVEMBER 29TH
 
TOCQUEVILLE
9:00 – 11:00 AM
MAXIMIZING THE IMPACT OF CLINICAL TRIAL FINDINGS:
NIH FUNDING OPPORTUNITIES FOR DISSEMINATION & IMPLEMENTATION RESEARCH
CVCT – NHLBI Joint Workshop
Moderators: Michael Engelgau (NHLBI, USA); Catherine Stoney (NHLBI, USA)

NIH is the largest public funder of clinical trials in the United States with NHLBI being the primary Institute responsible for heart, lung, blood, and sleep-related research funding. Over the last couple of years, NIH has embarked in a comprehensive reform process with the overall goal of improving the quality and effi ciency of the clinical trials it supports. NHLBI has been at the forefront of this effort, by developing new specifi c Funding Opportunity Announcement (FOA) for the different types of clinical trials it supports, from early phases to large multisite trials. The workshop will review the different types of FOAs available to clinical investigators and their specifi c requirements, with special focus on specifi c opportunities for new or early stage investigators.

The goals of this NIH workshop are to highlight the role of dissemination and implementation research in improving and accelerating the translation of evidence-based cardiovascular clinical trials research fi ndings to clinical practice, to provide a high-level review of successes of dissemination and implementation trials in this area, and to share key strategies for successful NIH review and funding of these applications. While early-stage investigators may be especially interested in participation, this seminar will be broadly relevant to cardiovascular researcher’s at all professional stages who are interested in dissemination and implementation science. Opportunities for questions and brief discussions will be integrated into the program.

présentation
  • Grand Challenges: Clinical Trial Findings and Quality Cardiovascular Health Care Delivery
    Laurence Sperling (Atlanta, USA)
présentation
  • Dissemination and Implementation Research Clinical Trials to the Rescue
    Catherine Stoney (NHLBI, USA)
  • How to Navigate Successful NIH Peer Review of Your D&I Clinical Trial Application
    Brian Mittman (Kaiser Permanente, USA)
présentation
  • NHLBI and Other NIH Funding Opportunities for Clinical Trials in D&I Research
    David C. Goff (NHLBI, USA)
 
BALLROOM

9:30 AM – 3:30 PM

CVCT MASTER CLASS DESIGN, DATA MONITORING AND REPORTING OF CLINICAL TRIALS
Stuart Pocock (London, GBR); Janet Wittes (Washington, USA)
(REQUIRES SPECIFIC REGISTRATION)

 
  • Learning Objectives
    To provide a comprehensive review of important statistical and scientific aspects of major clinical trials in cardiovascular diseases
  • Target audience
    The content will be aimed at cardiologists, regulators, academic scientists, and statisticians: indeed all health professionals wanting to expand their knowledge of how to design, conduct, monitor, analyse, report and interpret a major randomized trial.
  • Course Description
    The course will comprise three 90 minute sessions, one each on trial design, data monitoring, and reporting.
 
Topics covered will include the following:
• The two lecturers will actively encourage audience participation in a lively discussion
• Topics will be illustrated by real examples of cardiovascular trials
• All three parts will be full of topical examples to illustrate each point.
• Throughout common sources of bias that arise in designing, monitoring, and reporting about trials, will be pointed out.
The goal is to structure the whole experience to be of direct practical value. Appropriate references to enhance knowledge further will be provided.
 
présentation
  • Part 1: Designing the Trial and Statistical Fundamentals
    Types of trial; choices of patients, treatments and outcomes; randomization, how and why; blinding, how and why; size of trials and power calculations; non-inferiority trials; factorial trials.
    Hypothesis testing, including the value and the misuse of P-values; estimation of treatment effects; Kaplan Meier plots; expressing uncertainty using confidence intervals; need for both absolute and relative effect measures.
présentation
  • Part 2: Monitoring the Ongoing Data
    The role and function of Data Monitoring Committee: practicalities, ethics and statistics of monitoring accumulating data; stopping for efficacy, for futility or for safety; statistical stopping guidelines; adaptive designs; the reality of decision-making when data suggest it’s time to stop a trial.
présentation
  • Part 3: Reporting the Results
    Multiplicity of data, hierarchical testing; handling of composite endpoints, subgroup analyses and covariate-adjusted analyses; intention-to-treat and per-protocol analyses; balancing efficacy and safety; Bayesian methods; constructive critical appraisal.
 
BALLROOM

4:00 – 6:30 PM

PATIENT – TRIALISTS FORUM
HOW TO SECURE PATIENTS’ PARTICIPATION AS RESEARCH PARTNERS IN CLINICAL TRIALS?
 
Moderators: Cynthia Chauhan (Wichita, USA); Annemieke Lenselink (The Hague Area, NED)
The aim of this session is to familiarize the researchers with the contributions, concerns and viewpoints of patients as well as to offer the researchers and patients an opportunity to dialogue meaningfully on the issue of patient engagement in the development of and participation in clinical trials. The outcome of this session would include broader understanding of the issues patients consider in choosing to enter trials and result in the potential for better engagement and accrual with less early withdrawal. When researchers understand and value the unique contribution of the patient perspective they may be more likely to include patients as team members from inception of the concept. No matter their level of engagement, it is important for patients to see themselves and be recognized as research partners or participants, never subjects.
 
Introduction:
  • Cynthia Chauhan (Wichita, USA), HFpEF and Renal Failure
  • Annemieke Lenselink (The Hague Area, NED), Stroke
 
FDA Patient Focused Drug Development: Our Learnings to Date
présentation Theresa Mullin (FDA, USA)
EMA perspective
présentation Angeles Alonso (EMA, GBR)
 
The Patient Perspective:
  • Patient engagement in trial design
  • Heart failure with Reduced EF and Pacemaker with Defibrillator
    Kirsten Dahlgren (Michigan, USA)
  • Dilated Cardiomyopathy
    Natascha van der Post (Nijmegen Area, NED)
 
  • Enrolment/Accrual and Retention Issues
  • Congenital Heart Disease
    Stefan Teunis (Oldenzaal, NED)
  • End Stage Hypertrophic Cardiomyopathy
    Marion van Sinttruije (Zwolle, NED)
 
Q & A DISCUSSION
 
  • Patients with comorbidities, how do they fit into trials?
    Patrick Gee (Chesterfield, USA), Kidney disease
               Steven Macari (Poitiers, FRA), Heart failure with reduced EF, implanted CRT-D, diabetes
  • Inclusion of minorities in trials
    Sadegh Alikhaani (Los Angeles, USA), Heart Attack and Jacqueline Alikhaani (Los Angeles, USA), ARCA
 
Q & A DISCUSSION
 
  • Patient reported outcomes, how important are they?
    Jillianne Code (Vancouver, CAN), Idiopathic Cardiomyopathy and Heart Transplantation
  • Trial outcomes, what matters to patients
    Jayna Williams (New Hampshire, USA), Dilated Cardiomyopathy with Heart Failure with Reduced EF
               Robin Martinez (Denver, USA), Kidney Disease
 
Q & A DISCUSSION
 
  • Trialist Perspective
    Ileana Piña (New York, USA)
  • Industry Perspective
    Monica Shah (IQVIA, USA)
               Helina Kassahun (Amgen, USA)
 
THE FORUM
Moderated Multi-Stakeholder Expert Panel Debate with the Audience
 
Panelists: Tariq Ahmad (New Haven, USA); Sadegh Alikhaani (Los Angeles, USA); Jacqueline Alikhaani (Los Angeles, USA); Angeles Alonso (EMA, GBR); Cynthia Chauhan (Wichita, USA); Jillianne Code (Vancouver, CAN); Kirsten Dahlgren (Michigan, USA); Patrick Gee (Chesterfi eld, USA); Larry Husten (Cardiobrief, USA); Stefan James (Upsala, SWE); Nichole Jefferson (Iowa, USA); Mariell Jessup (Philadelphia, USA); Helina Kassahun (Amgen, USA); Carolyn Lam (Singapore, SIN); Anna Maria Langkilde (AstraZeneca, SWE); Annemieke Lenselink (The Hague Area, NED); Gary Lyman (Raleigh, USA); Steven Macari (Poitiers, FRA); Véronique Mahaux (Syneos Health, BEL); Robin Martinez (Denver, USA); Manal Milhem (Atlanta, USA); Rhonda E. Monroe (Washington, USA); Theresa Mullin (FDA, USA); Milton Packer (Dallas, USA); Ileana Piña (New York, USA); Bertram Pitt (Ann Arbor, USA); Adel Rizkala (Novartis, USA); Matt Roe (Durham, USA); Yves Rosenberg (NHLBI, USA); Patrick Rossignol (Nancy, FRA); Juddson Rupp (Charlotte, USA); Rob Scott (Abbvie, USA); Monica Shah (IQVIA, USA); Tabassome Simon (Paris, FRA); Jeff A. Sloan (Rochester, USA); Kenneth Stein (Boston Scientifc, USA); Stefan Teunis (Oldenzaal, NED); Peter van der Meer (Groningen, NED); Natascha van der Post (Nijmegen Area, NED); Marion van Sinttruije (Zwolle, NED); Jayna Williams (New Hampshire, USA); Faiez Zannad (Nancy, FRA)
 
AUDITORIUM

9:00 – 11:00 AM

ATRIAL FIBRILLATION ABLATION (I)
HOW TO INTERPRET CABANA?
CVCT – HRS Joint Session
 
Moderators: Thomas Deering (Atlanta, USA); Gerhard Hindricks (Leipzig, GER)
The Catheter Ablation versus Standard Conventional Therapy in Patients with Left Ventricular Dysfunction and Atrial Fibrillation (CASTLE-AF) trial randomized 398 patients with paroxysmal or persistent atrial fibrillation and NYHA class II-IV HFrEF (LVEF ≤35%) to catheter ablation or medical therapy.
  • Fewer patients in the catheter ablation group experienced the primary composite outcome of death or hospitalization for worsening heart failure (28.5% vs. 44.6%, P=0.006).
  • Crossovers occurred in 9.8% of patients in the medical therapy group and 15.6% of the catheter ablation group.
  •  
    The Catheter Ablation versus Antiarrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial was a multicentre, prospective, randomized, open-label study comparing percutaneous left atrial catheter ablation to pharmacologic rate or rhythm control. The results were reported in May at the Heart Rhythm Society.
  • Among the 2,204 patients were enrolled, there was no difference in the primary outcome of total mortality, disabling stroke, serious bleeding, or cardiac arrest after 5 years of follow-up for patients randomized to ablation compared to drug therapy (8% vs. 9.2%, HR 0.86, 95% CI 0.65-1.15, P=0.3).
  • In this open-label trial, a high crossover from the drug therapy arm to ablation (27.5%) occurred. In an as treated analysis, ablation was superior to drug therapy on the primary composite outcome, as well as for all-cause mortality alone, and the composite of death or cardiovascular hospitalization.
  •  
    These findings raise important questions that will be discussed during the session:
  • How should the on-treatment analysis be used and/or applied in practice?
  • Do the results of CASTLE-AF and other data provide more confidence in the as-treated analysis of CABANA?
  • What accounts for the higher crossover in CABANA vs. CASTLE-AF?
  • Are sham-controlled trials always necessary to avoid the potential for crossovers? Would sham-controlled be ethical in light of CASTLE-AF?
  • Will physicians in practice (non-researchers) recognize the limitations of as treated analyses?
  •  
    • CABANA Key Outcome Points
      Kerry Lee (Durham, USA)
    • CABANA newest results (Quality of Life and Cost Analyses)
      Dan Mark (Durham, USA)
    présentation
    • Statistician Viewpoint
      Brian Claggett (Boston, USA)
    présentation
    • NHLBI perspective
      Yves Rosenberg (NHLBI, USA)
    présentation
    • CASTLE-AF and other recent and ongoing trials
      Nassir Marrouche (Salt Lake City, USA)
    • Electrophysiologist Viewpoint
      EU: Gerhard Hindricks (Leipzig, GER)
      US: Conor Barrett (Boston, USA)
    présentation
    • Non-Electrophysiologist Viewpoint
      EU: Lars Lund (Stockholm, SWE)
    présentation US: Bernard Gersh (Rochester, USA)
     
    Q & A DISCUSSION
     
    AUDITORIUM

    11:30 AM – 1:00 PM

    ATRIAL FIBRILLATION ABLATION (II)
    STAKEHOLDERS VIEWPOINTS
    CVCT – HRS Joint Session
     
    Moderators: Thomas Deering (Atlanta, USA); Gerhard Hindricks (Leipzig, GER)
     
    présentation
    • Regulatory viewpoint
      Jun Dong (FDA, USA)
    • Industry viewpoint
      Kenneth Stein (Boston Scientifc, USA)
    • Media Viewpoint
      Larry Husten (Cardiobrief, USA)
    • Patient Viewpoint:
      Kirsten Dahlgren (Michigan, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    WHAT’S NEXT? INTERPRETATION AND IMPLEMENTATION ISSUES
     
    Panelists: Conor Barrett (Boston, USA); Brian Claggett (Boston, USA); Nikolaos Dagres (Leipzig, GER); Kirsten Dahlgren (Michigan, USA); Thomas Deering (Atlanta, USA); Jun Dong (FDA, USA); Bernard Gersh (Rochester, USA); Gerhard Hindricks (Leipzig, GER); Larry Husten (Cardiobrief, USA); Kerry Lee (Durham, USA); Lars Lund (Stockholm, SWE); Dan Mark (Durham, USA); Nassir Marrouche (Salt Lake City, USA); Yves Rosenberg (NHLBI, USA); Kenneth Stein (Boston Scientifc, USA)
     
    AUDITORIUM

    2:00 – 3:30 PM

    ATHEROSCLEROSIS TRIALS (I)
    TARGETING THE APPROPRIATE MECHANISM
     
    Moderators: Wolfgang Koenig (Munich, GER); Robert S. Rosenson (New York, USA)

    Residual risk still represents an important issue in patients with manifest cardiovascular disease despite standard of care treatment with approximately 20% of patients experiencing a recurrent event within 5 years after an ACS. Several additional strategies are presently in place or are being investigated in large clinical trials like aggressive lowering of LDL cholesterol by PCSK9 inhibition or an RNA silencing mechanism, lowering of Lp (a), and finally triglycerides (TG) have seen a revival and their lowering is presently being tested in several trials applying different interventions like high-dose omega-3 and 6 or a SPARM (selective PPAR- modulator). But novel strategies are at the horizon.

    The recently presented ODYSSEY trial showed a 15 % relative risk reduction (RRR) (absolute risk reduction 1,6%) of the primary efficacy endpoint consisting of CHD, death, non-fatal MI, ischemic stroke or unstable angina requiring hospitalization in post-ACS patients thus extending the results from FOURIER to a higher risk cohort. However, there are several issues that need clarification, such as the reported decrease in all-cause deaths without a significant decrease in CHD death or cardiovascular death and the increase in LDL-C over the study’s duration both in the ITT group (40 mg/dl to 66 mg/dl) and the on-treatment group (38 mg/dl to 53 mg/dl). At present, it is still unclear what the reasons for these changes are. By contrast, FOURIER reported a flat 30 mg/dl level throughout the whole study period. In addition, recent post-hoc analyses from FOURIER have highlighted specific high-risk subgroups, such as patients with peripheral arterial disease (PAD), multi-vessel disease, or a recent MI, that may derive greater benefit compared to the overall study population. Similarly, in ODYSSEY, those with a baseline LDL-C > 100 mg/dl showed a 29% RRR compared to 15% in the total study population. Thus, although basically confirming the results of FOURIER, there are still a number of remaining questions that require further discussion, including the observation that in every day clinical practice there appears to be a number of patients that either demonstrate an inadequate response or experience an attenuation of the effect over time.

    Lp(a) has been identified as an additional risk factor based among others on convincing results from Mendelian Randomisation Studies. Yet, is is still unclear whether additional Lp(a) lowering on top of aggressive LDL-C lowering confers any clinically relevant benefit. Options to selectively lower Lp(a) are under way.

    On the other hand, the positive CANTOS study clearly has paved the way for the introduction of anti-inflammatory treatment in high-risk patient’s post-ACS. Several recent additional analyses have identified high-risk groups and in particular high responders based on robust changes of the biomarker hs-CRP three months after the first injection. In addition data from CIRT, a trial investigating low-dose methotrexate in high risk patients will probably be presented during AHA this year. Still, in CANTOS as well as in FOURIER and ODYSSEY, a significant number of patients went on to have a second event. Thus, additional strategies are needed.

    Most recently, two studies have reported that even at extremely low levels of LDL cholesterol, <20 mg/ dl, hs-CRP still is able to modify risk in these patients suggesting that inflammation might play a role even in these patients and we should not alternatively choose between a residual cholesterol risk or a residual inflammatory risk but rather consider a combination of these two strategies..

     
    PCSK9 inhibitor trials
     
    présentation
    • ODYSSEY: Did it achieve its goals?
      Shaun Goodman (Toronto, CAN)
    présentation
    • FOURIER: Identifying very high-risk groups
      Marc Sabatine (Boston, USA)
    présentation
    • Statistical and meta-analytical viewpoint
      Usman Baber (New York, USA)
     
    Q & A DISCUSSION
     
    Trials of agents targeting inflammation
     
    • CANTOS: Recent Analyses Paving the way for Individualized Treatment
      Peter Libby (Boston, USA)
    présentation
    • CIRT Trial: Implications for an Anti-Inflammatory Strategy
      Ahmed Hasan (NHLBI, USA)
     
    Q & A DISCUSSION
     
    AUDITORIUM

    4:00 – 6:30 PM

    ATHEROSCLEROSIS TRIALS (II)
    TARGETING THE APPROPRIATE MECHANISM AND STAKEHOLDERS VIEWPOINTS
     
    Moderators: Wolfgang Koenig (Munich, GER); Robert S. Rosenson (New York, USA)
     
    Residual cholesterol risk vs. residual inflammatory risk or combining both?
     
    présentation
    • Inflammation does play a significant role even at very low LDL levels
      Erin Bohula (Boston, USA)
    présentation
    • Inflammation is no longer relevant in patient on very low LDL levels
      Erin Michos (Baltimore, USA)
     
    Q & A DISCUSSION
     
    Selective reduction of Lp (a)
     
    • Lp (a) in FOURIER
      Michelle O’Donoghue (Boston, USA)
    • Still clinically relevant in patients after MI on an optimized LDL-C lowering strategy
      Brian Ference (Cambridge, GBR)
     
    Q & A DISCUSSION
     
    • Industry Viewpoints
      Jean Marc Guettier (Sanofi , FRA); Andrew Hamer (AMGEN, USA)
    présentation
    • Regulatory Viewpoints
      William Chong (FDA, USA); Alar Irs (EMA, EST)
    présentation
    • Payers Viewpoints:
      Alejandro Arrieta (Miami, USA)
    • Patient Viewpoints:
      Cat Davis Ahmed (The FH Foundation, USA); Wanda F Moore (Arizona, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    APPROVAL, IMPLEMENTATION AND REIMBURSEMENT CHALLENGES
     
    Panelists: Cat Davis Ahmed (The FH Foundation, USA); Alejandro Arrieta (Miami, USA); Usman Baber (New York, USA); Erin Bohula (Boston, USA); William Chong (FDA, USA); Brian Ference (Cambridge, GBR); Augusto Gallino (ISCP, CHE); Shaun Goodman (Toronto, CAN); Jean Marc Guettier (Sanofi , FRA); Andrew Hamer (AMGEN, USA); Ahmed Hasan (NHLBI, USA); Alar Irs (EMA, EST); Wolfgang Koenig (Munich, GER); Peter Libby (Boston, USA); Erin Michos (Baltimore, USA); Wanda F Moore (Arizona, USA); Michelle O’Donoghue (Boston, USA); Robert S. Rosenson (New York, USA); Marc Sabatine (Boston, USA)
     
     
     
     
    FRIDAY, NOVEMBER 30th
     
    TOCQUEVILLE
    4:00 – 7:00 PM
    ASN-KHI-CVCT Joint Focused Workshop
    POTASSIUM BINDERS ENABLING OPTIMIZATION OF RAAS INHIBITOR THERAPY.
    WHAT EVIDENCE IS NEEDED?
    ON INVITATION ONLY – CLOSED WORKSHOP
    Focused CVCT Workshops are organized as campfire-sessions, fit for smaller groups:
    The expert and the participants sit in a small U shape-table, as equals.
    The experts are allowed very brief openings, but then it is over to the participants,
    with the hope that intimacy allows participants to feel freer
    to talk to the expert and to each other.

    ACE inhibitors, ARBs, MRAs and ARNi have shown signifi cant clinical benefi t in a variety of diseases including heart failure, patients at high CV risk, diabetes, and CKD. Yet they are under-prescribed, frequently discontinued and/or under-dosed in real world registry data. Suboptimal use is associated with poor outcome One major driver of under use, discontinuation or under dosing is hyperkaliemia, a consistent and frequent adverse event. Patients at risk of hyperkalemia are those very patients at most need for RAAS inhibitors, i.e elderly, CKD, diabetes pts, and pts with history of hyperkalemia episodes. Whether the use of potassium binders may help enabling optimal use of life saving RAASi therapies, and therefore improve outcome in pts at risk is a question which needs to be based on appropriate evidence. The objective of this focused workshop is to assemble a think tank of critical stakeholders discussing unmet needs, evidence to be generated, data to be collected, potential studies, registries, and trials to be developed, and implementation strategies to be designed for an optimal use of potassium binders enabling optimization of RAAS inhibitor therapy.

     
    Moderators: Ileana Piña (New York, USA); Patrick Rossignol (Nancy, FRA)
     
    Registries and Real World Evidence: Value, Feasibility, Design, Translatability
     
    présentation
    • Nephrology Viewpoint
      Prabir Roy Chaudhury (Tucson, USA)
    présentation
    • Cardiology Viewpoint
      Lars Lund (Stockholm, SWE)
    présentation
    • Challenges in Clinical trials: Defi ning Novel Endpoints in RAASi Enabling Trials
      Aliza Thompson (FDA, USA)
     
    Q & A DISCUSSION
     
    5:00 – 6:00 PM
    Implementation issues
     
    Moderators: Moderators: Prabir Roy Chaudhury (Tucson, USA); James Januzzi (Boston, USA)
     
    How to better streamline cardiologist – nephrologist collaboration in the management of hyperkalemia?
     
    • Cardiologist Viewpoint
      Charles Herzog (Minneapolis, USA)
    présentation
    • Nephrologist Viewpoint
      George Bakris (Chicago, USA)
     
    • The Way to Guidelines
      Ileana Pina (New York, USA
     
    Patient Viewpoint
     
    • Kidney disease
      Patrick Gee (Chesterfi eld, USA)
    • Heart failure with reduced EF, implanted CRT-D, diabetes
      Steven Macari (Poitiers, FRA)
     
    Q & A DISCUSSION
     
    6:00 – 7:00 PM
    Panel Discussion - Industry Viewpoint
     
    Moderators: Colin Baigent (Oxford, GBR), Bertram Pitt (Ann Arbor, USA)
     
    Panelists: William Abraham (Columbus, USA); Colin Baigent (Oxford, GBR); George Bakris (Chicago, USA); Justin Ezekowitz (Edmonton, CAN); Patrick Gee (Chesterfi eld, USA); Jyothis George (Boehringer, GER); Charles Herzog (Minneapolis, USA); James Januzzi (Boston, USA); Csaba Kovesdy (Nashville, USA); Lars Lund (Stockholm, SWE); Steven Macari (Poitiers, FRA); Alexandre Mebazaa (Paris, FRA); Robert Mentz (Durham, USA); Carol Moreno Quinn (AstraZeneca, SWE); Claudio Mori (Vifor Pharma, SWI); Milton Packer (Dallas, USA); Bertram Pitt (Ann Arbor, USA); Ileana Pina (New York, USA); Prabir Roy Chaudhury (Tucson, USA); Wilson Tang (Cleveland, USA); Aliza Thompson (FDA, USA); Peter van der Meer (Groningen, NED); Fred Yang (KBP Biosciences, USA); Faiez Zannad (Nancy, FRA); Emmanouil Zouridakis (EMA, GBR
     
    BALLROOM
    8:00 – 10:00 AM
    THROMBOCARDIOLOGY TRIALS (I)
     
    Moderators: Roxana Mehran (New York, USA); Tabassome Simon (Paris, FRA)
     
    Anti-Thrombotic Strategies: Latest Findings from NOACs Clinical Trials
     
    présentation
    • 1. In Atrial Fibrillation
      Elaine Hylek (Boston, USA)
    • 2. In Coronary and Peripheral Vascular Disease
      Kelley Branch (Washington, USA)
    présentation
    • 3. In Heart Failure
      Faiez Zannad (Nancy, FRA)
    présentation
    • 4. After Hospital Discharge for Medical Patients
      Jeffrey Weitz (Hamilton, CAN)
    présentation
    • 5. In Oncology
      Jeffrey Weitz (Hamilton, CAN)
    présentation
    • Is There Room for yet Another Anticoagulant?
      Jeffrey Weitz (Hamilton, CAN)
    présentation
    • DAPT Post-ACS: Twice as Nice, or Double the Trouble?
      Shaun Goodman (Toronto, CAN)
     
    Q & A DISCUSSION
     
    BALLROOM

    10:30 AM – 12:30 PM

    THROMBOCARDIOLOGY TRIALS (II)
     
    Moderators: Roxana Mehran (New York, USA); Tabassome Simon (Paris, FRA)
     
    Polypharmacy Anticoagulation: How to Study and Treat Combined Disorders Effectively and Safely?
     
    présentation
    • 1. ACS, Atrial Fibrillation, DES, TAVR
      David Moliterno (Lexington, USA)
    présentation
    • 2. Phenotype-Guided Strategies (Platelet Function and Whole-Blood Clotting)
      Tabassome Simon (Paris, FRA)
    présentation
    • 3. Biomarker and Risk Score Guidance (HASBLED, CHADSVASC, biomarkers)
      Jonas Oldgren (Uppsala, SWE)
    • Regulatory Viewpoint
      Ellis Unger (FDA, USA)
    présentation              Emmanouil Zouridakis (EMA, GBR)
    • Industry Viewpoint
      Efthymios Deliargyris (PLX Pharma Inc, USA) - Pete Di Battiste (Janssen, USA)- Melanie Goth (Bayer, GER)
    présentation              Martin Unverdorben (Daiichi Sankyo, USA)
    • Patient Viewpoint
      Annemieke Lenselink (The Hague Area, NED)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    HOW CAN WE BEST ADAPT TO THE FAST CHANGE IN LANDSCAPE?
     
    Panelists: Kelley Branch (Washington, USA); Efthymios Deliargyris (PLX Pharma Inc, USA); Pete Di Battiste (Janssen, USA); Shaun Goodman (Toronto, CAN); Melanie Goth (Bayer, GER); Elaine Hylek (Boston, USA); Annemieke Lenselink (The Hague Area, NED); Roxana Mehran (New York, USA); David Moliterno (Lexington, USA); Jonas Oldgren (Uppsala, SWE); Gary Raskob (Oklahoma, USA); Tabassome Simon (Paris, FRA); Ellis Unger (FDA, USA); Martin Unverdorben (Daiichi Sankyo, USA); Jeffrey Weitz (Hamilton, CAN); Faiez Zannad (Nancy, FRA); Emmanouil Zouridakis (EMA, GBR)
     
    BALLROOM

    2:00 – 3:30 AM

    eSOLUTIONS: BIG DATA – SMART DATA AND HOW THESE MAY HELP WITH CLINICAL
    EVIDENCE GENERATION
    CVCT- Duke Think Tank Joint Session (II)
     
    Moderator: Martin Cowie (London, GBR); Matt Roe (Durham, USA)
    The increasing availability of large quantities of data from multiple sources, coupled with advances in computing technology, have created opportunities to transform observational research and complement the evidence generated by randomized clinical trials. Big data compiled from single or multiple sources (e.g., registries, biobanks, electronic health records, claims or billing databases, implantable devices, mobile platforms) may provide some solutions to the challenges facing cardiovascular clinical research and the limitations of randomized trials (e.g., generalizability, resource availability, practicality for common clinical questions). However, best practices for the application or interpretation of data from these sources is often uncertain. Leaders in the field have an opportunity to guide the evolution of big data and its application to cardiovascular research and practice.
     
    présentation
    • Use of Big Data and AI in Clinical Trials
      Tariq Ahmad (New Haven, USA)
    présentation
    • Example of a Virtual Trial
      Matt Roe (Durham, USA)
    • mHealth solutions, health apps and e-Tools for clinical trials
      Helina Kassahun (Amgen, USA)
    présentation
    • Risk Based Monitoring
      Jennifer Schumi (Astrazeneca, SWE)
     
    Q & A DISCUSSION
     
    BALLROOM

    4:00 – 5:30 PM

    eSOLUTIONS: BIG DATA – SMART DATA AND HOW THESE MAY HELP
    WITH CLINICAL EVIDENCE GENERATION
    CVCT- Duke Think Tank Joint Session (II)
     
    Moderators: Martin Cowie (London, GBR); Matt Roe (Durham, USA)
     
    • The Transcelerate Initiative
      Rob Scott (Abbvie, USA)
    • Data-driven Solutions: Data-Driven Protocol Design, Approaches to Optimize Site Selection and Trial Implementation.
      Allen Kindman (IQVIA, USA)
     
    Q & A DISCUSSION
     
    BALLROOM

    5:30 – 7:00 PM

    eSOLUTIONS – BIG DATA – SMART DATA AND HOW THESE MAY HELP WITH CLINICAL
    EVIDENCE GENERATION
    CVCT & Duke Think-Tank Joint Session (III)
    STAKEHOLDER VIEWPOINT
     
    Moderator: Martin Cowie (London, GBR); Matt Roe (Durham, USA)
     
    présentation
    • Will Digital Make My Life Easier?
      Javed Butler (Jackson, USA)
    • Industry Viewpoint
      Helina Kassahun (Amgen, USA)
    présentation
    • Academic CRO Viewpoint
      Matt Roe (Durham, USA)
    présentation
    • CRO Viewpoint
      Gadi Cotter (Momentum Research, USA)
    présentation
    • NHLBI Viewpoint
      Gail Pearson (NHLBI, USA)
    • Media Viewpoint
      Larry Husten (Cardiobrief, USA)
    présentation
    • The National Patient Centered Clinical Research Network (PCORnet)
      Adrian Hernandez (Durham, USA)
    • Patient Viewpoint
      Robin Martinez (Denver, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    HOW SHOULD WE BRING THE DIGITAL REVOLUTION INTO CLINICAL TRIALS?
     
    Panelists: Tariq Ahmad (New Haven, USA); Javed Butler (Jackson, USA); Gadi Cotter (Momentum Research, USA); Martin Cowie (London, GBR); Adrian Hernandez (Durham, USA); Larry Husten (Cardiobrief, USA); Helina Kassahun (Amgen, USA); Allen Kindman (IQVIA, USA); Robin Martinez (Denver, USA); Gail Pearson (NHLBI, USA); Matt Roe (Durham, USA); Jennifer Schumi (Astrazeneca, SWE); Rob Scott (Abbvie, USA);
     
    AUDITORIUM

    8:00 –10:00 AM

    CVCT & INI – CRCT Joint Session
    CARDIORENAL OUTCOME TRIALS IN METABOLIC DISORDERS (I)
    NEW TRIALS - NEW PARADIGMS
     
    Moderators: Colin Baigent (Oxford, GBR); Milton Packer (Dallas, USA)
    Cardiovascular outcome trials in patients with type 2 diabetes mellitus and cardiovascular disease (or with major cardiovascular risk factors) have shown that some glucose lowering drugs reduce the composite risk of CV death, MI, and stroke when added to standard of care, compared to standard of care alone. These findings reinforce the importance of moving beyond a glucocentric approach to the management of type 2 diabetes mellitus to reduce cardiovascular risk. Although cardiovascular outcome trials were initially required to rule out cardiovascular harm of glucose lowering drugs, the findings from these trials support a position that clinical trials in patients with cardiometabolic disease should be evaluating efficacy (superiority). Conducting trials only to rule out harm (non-inferiority) without other evidence of meaningful clinical benefit should be re-evaluated. Not all cardiovascular outcome trials conducted in patients with type 2 diabetes mellitus have yielded superior results compared to standard therapy, raising the possibility that pharmacologic differences among agents may translate into tangible differences in clinical efficacy. The implications of these differences on the need to conduct cardiovascular outcome trials with every agent in a drug class needs further discussion. Cardiovascular outcome trials in type 2 diabetes mellitus also signal an opportunity to explore the treatment effects of these and other cardioprotective agents in patients with other cardiometabolic and cardiorenal diseases.
     
    présentation
    • SGLT-2 Inhibitors Cardiovascular Outcome Trials
      Marc Sabatine (Boston, USA)
    présentation
    • Other SGLT-2 Inhibitors Renal Outcome Trials
      Colin Baigent (Oxford, GBR)
    présentation
    • Any value in a cardiorenal composite outcome?
      Faiez Zannad (Nancy, FRA)
    présentation
    • GLP1RA Trials
      Robert Mentz (Durham, USA)
                   Salim Janmohamed (GSK, GBR)
    présentation              Jeff Riesmeyer (Lilly, USA)
    • DPPIV Inhibitors
      Jacob Udell (Toronto, CAN)
     
    AUDITORIUM

    10:00 AM – 12:30 PM

    CVCT & INI – CRCT Joint Session
    CARDIORENAL OUTCOME TRIALS IN METABOLIC DISORDERS (II)
    STAKEHOLDERS VIEWPOINTS
     
    Moderators: Colin Baigent (Oxford, GBR); Milton Packer (Dallas, USA)
     
    présentation
    • Mechanistic Speculations About the Cardiorenal Benefits of New Glucose Lowering Agents
      Milton Packer (Dallas, USA)
    présentation
    • Should Metformin Remain First-Line Medical Therapy? What is the Preferred Second Line Glucose Lowering Agent for Patients with Type 2 Diabetes Mellitus and Atherosclerotic Cardiovascular Disease?
      Muthu Vaduganathan (Boston, USA)
    présentation
    • CV Protection Trials in Obesity: CV Safety or Efficacy Trials?
      Donna Ryan (Baton Rouge, USA)
    • CV Protection Trials in NASH: CV Endpoints for CV Claims?
      Arun Sanyal (Richmond, USA)
     
    AUDITORIUM
    présentation
    2:00 – 3:30 PM

    CVCT & INI – CRCT Joint Session
    CARDIORENAL TRIALS IN METABOLIC DISORDERS (III)
    IS R&D AND REGULATORY LANDSCAPE EVOLVING?
     
    Moderators: Colin Baigent (Oxford, GBR); Milton Packer (Dallas, USA)
     
    • Statistician Viewpoint
      Stuart Pocock (London, GBR)
    présentation
    • Industry Viewpoint
      Jyothis George (Boehringer, GER)
    présentation              Anna Maria Langkilde (AstraZeneca, SWE)
    présentation              Francesca Lawson (Sanofi , FRA)
    présentation
    • Funding Agencies Viewpoint
      Judith Fradkin (NIDDK, USA)
    • Regulatory Viewpoints
      Kristina Dunder (EMA, SWE)
                   Kimberly Smith (CDER-FDA, USA)
                   Lisa Yanoff (FDA, USA)
    • Patient Viewpoint
      Cynthia Chauhan (Wichita, USA)
                   Patrick Gee (Chesterfi eld, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
     
    Panelists: Colin Baigent (Oxford, GBR); Cynthia Chauhan (Wichita, USA); Kristina Dunder (EMA, SWE); Judith Fradkin (NIDDK, USA); Patrick Gee (Chesterfi eld, USA); Jyothis George (Boehringer, GER); Salim Janmohamed (GSK, GBR); Francesca Lawson (Sanofi , FRA); Anna Maria Langkilde (AstraZeneca, SWE); Barbara Linder (NIDDK, USA); Robert Mentz (Durham, USA); Milton Packer (Dallas, USA); Stuart Pocock (London, GBR); Donna Ryan (Baton Rouge, USA); Marc Sabatine (Boston, USA); Arun Sanyal (Richmond, USA); Kimberly Smith (CDER-FDA, USA); WH Wilson Tang (Cleveland, USA); Jacob Udell (Toronto, CAN); Muthu Vaduganathan (Boston, USA); Lisa Yanoff (FDA, USA); Faiez Zannad (Nancy, FRA)
     
    AUDITORIUM

    4:00 – 5:30 PM

    STABLE ISCHEMIC HEART DISEASE TRIALS (I)
     
    Moderators: Shaun Goodman (Toronto, CAN); David Moliterno (Lexington, USA)
     
    Endpoint Related Issues
     
    présentation
    • How to Best Design Clinical Trials in SIHD?
      David Moliterno (Lexington, USA)
    présentation
    • Defining the Right Endpoints (soft versus hard) for Regulators, Companies, Physicians, and Patient
      Don Cutlip (Boston, USA)
    • Are Results of Slow Enrolling Trials Relevant with Current Practice? ISCHEMIA, OAT, COURAGE
      Roxana Mehran (New York, USA)
    présentation
    • Sham design: Feasibility, Ethics and Late Crossover Issues
      Darrel Francis (London, GBR)
     
    Q & A DISCUSSION
     
    AUDITORIUM

    5:30 – 7:00 PM

    STABLE ISCHEMIC HEART DISEASE TRIALS (II)
    STAKEHOLDER VIEWPOINT
     
    Moderators: Shaun Goodman (Toronto, CAN); David Moliterno (Lexington, USA)
     
    présentation
    • Statistical: Methodological Considerations
      Peter Jüni (Toronto, CAN)
    présentation
    • Funding Agencies Viewpoint
      Yves Rosenberg (NHLBI, USA)
    • Regulatory Viewpoint
      Bram Zuckerman (FDA, USA)
    • Patient Viewpoint
      Cynthia Chauhan (Wichita, USA)
                   Susan Quella (Rochester, USA)
     
    Q & A DISCUSSION
     

    7:00 – 7:30 PM

    Cheese & Wine Poster Session
     

    7:30 – 9:00 PM

    Networking Reception
     
     
     
    SATURDAY, DECEMBER 1ST
     
    BALLROOM

    8:00 - 10:00 AM

    REAL WORLD DATA (I)
    IS IT REAL WORLD EVIDENCE?
     
    Moderators: John Jarcho (NEJM, USA) ; Mariell Jessup (Philadelphia, USA)

    The 21st Century Cures Act requires the FDA to develop a framework and guidance for evaluating real world evidence (RWE) to support approvals of new indications for previously approved drugs and to support or fulfil post-approval study requirements. This needs to be done within the next 2 years.

    How can we help to support and input into this process? The four main stakeholder groups with influence in the drug development process, i.e. trialists, regulators, payers, practitioners and patients may have different insights on how RWE can be made highly credible, if at all possible.

     
    Potential Implications of the 21st Century Cures Act in Relation to the Use of RWE: The Changing Regulatory Landscape
     
    présentation EU: Robert Califf (Durham, USA)
    présentation Europe: Martin Cowie (London, GBR)
     
    présentation
    • How the Increasing Use of RWE Will Impact Future Designs and Implementation of Phase II-III Clinical Development Programs?
      Phil Galtry (Syneos Health, BEL)
    présentation
    • Registry Data and How these May Help Evidence Generation
      Kirkwood Adams (Chapel Hill, USA)
    présentation              Stefan James (Upsala, SWE)
    présentation
    • Can Registry-Based Randomized Clinical Trials Bridge the Evidence Gap?
      Stefan James (Upsala, Sweden)
    • From Frequentist to Bayesian to RWE
      Bernard Vasseur (FDA, USA)
     
    Q & A DISCUSSION
     
    BALLROOM

    10:30 AM - 12:30 PM

    eREAL WORLD DATA (II)
    STAKEHOLDERS VIEWPOINT
     
    Moderators: John Jarcho (NEJM, USA); Mariell Jessup (Philadelphia, USA)
     
    présentation
    • Trialist Viewpoint: Only Trials Can Tell the Truth!
      Milton Packer (Dallas, USA)
    présentation
    présentation
    • Industry Viewpoint
      Anna Maria Langkilde (AstraZeneca, SWE); Nirav Dalal (Abbott, USA)
    présentation
    • CRO Viewpoint
      Jennifer Christian (IQVIA, USA)
    présentation
    • Issues with Clinical Research Publication: What to Trust or Not to Trust?
      Joseph Hill (Dallas, USA)
    présentation
    • Journal Editors Viewpoint
      John Jarcho (NEJM, USA)
                   Stuart Spencer (The Lancet, GBR)Stuart Spencer (The Lancet, GBR)
    présentation
    • Regulatory Viewpoint: What is “Regulatory Grade” Real World Evidence?
      David Martin (FDA, USA); Alar Irs (EMA, EST)
    • Patient Viewpoint
      Jeff A. Sloan (Rochester, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    REAL WORLD EVIDENCE VS. CLINICAL TRIAL EVIDENCE.
    HOW TO MAKE THE BEST OF BOTH WORDS?
     
    Panelists: Kirkwood Adams (Chapel Hill, USA); Robert Califf (Durham, USA); Jennifer Christian (IQVIA, USA); Martin Cowie (London, GBR); Nirav Dalal (Abbott, USA); Efthymios Deliargyris (PLX Pharma Inc, USA); Phil Galtry (Syneos Health, BEL); Joseph Hill (Dallas, USA); Alar Irs (EMA, EST); Stefan James (Upsala, SWE); John Jarcho (NEJM, USA); Mariell Jessup (Philadelphia, USA); Anna Maria Langkilde (AstraZeneca, SWE); Véronique Mahaux (Syneoshealth, BEL); David Martin (FDA, USA); Milton Packer (Dallas, USA); Monica Shah (IQVIA, USA); Jeff A. Sloan (Rochester, USA); Stuart Spencer (The Lancet, GBR); Bernard Vasseur (FDA, USA)
     
    BALLROOM

    2:00 - 4:00 PM

    DRUG ELUTING AND BIORESORBABLE VASCULAR STENTS TRIALS
     
    Moderators: Roxana Mehran (New York, USA); David Moliterno (Lexington, USA)
     
    présentation
    • DES trials: What Trials and How to Conduct?
      Don Cutlip (Boston, USA)
    présentation
    • DES in High Bleeding Risk Patients
      Christopher Granger (Durham, USA)
    présentation
    • BVS Trial Conduct and Results Implementation Issues
      Alexandre Abizaid (Sao Paulo, BRA)
    présentation
    • Endpoint Related Issues: Death, MI and Stent Thrombosis Events?
      David Moliterno (Lexington, USA)
    présentation
    • Regulatory Viewpoint
      Andrew Farb (FDA, USA), P.F. Adrian Magee (FDA, USA)
    présentation
    • Industry viewpoint
      Martin Unverdorben (Daiichi Sankyo, USA)
    • Patient Viewpoint
      Steven Macari (Poitiers, FRA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    EVIDENCE GENERATION AND IMPLEMENTATION ISSUES IN INTERVENTIONAL
    CARDIOLOGY. HOW TO DO A BETTER JOB?
     
    Panelists: Alexandre Abizaid (Sao Paulo, BRA); Don Cutlip (Boston, USA); Andrew Farb (FDA, USA); Christopher Granger (Durham, USA); Steven Macari (Poitiers, FRA); P.F. Adrian Magee (FDA, USA); Roxana Mehran (New York, USA); David Moliterno (Lexington, USA); Martin Unverdorben (Daiichi Sankyo, USA)
     

    4:00 - 7:00 PM

    GLOBALIZATION OF CV CLINICAL TRIALS
    OPPORTUNITIES, CHALLENGES AND UNMET NEEDS
    CVCT & ISCP Joint Session
     
    Moderators: Koji Hasegawa (Kyoto, JPN); Felipe Martinez (Cordoba, ARG)

    There are important potential advantages of conducting clinical research in a wider global setting such as better generalizability and lower cost. However, there are also important complexities and challenges that need to be considered.

    Research priorities may differ in global clinical trials. There are important regional differences including disease states (e.g. Chagas or rheumatic heart disease), therapeutic approaches (e.g. the polypill, lower dose requirements); patient populations (low economic development, younger patients, etc.) or genetic variations to therapeutic response (i.e. ACE-I).

    Variations in clinical setting and “usual care” may also influence the conduct of global clinical trials. Important country level differences may exist in the availability of established therapies; the use of non-standard treatments such as traditional Chinese medicine, and nutrition and lifestyle patterns (i.e. smoking).

    Additional challenges in developing countries may include unfamiliarity with clinical research standards and paradigms, difficulty with enrolment and monitoring; loss to follow-up etc. In contrast, in developed countries challenges may include reluctance of physicians and/or patients to enrol in trials, or scepticism related to big pharma. Such challenges may explain why the US is increasingly listed among the lowest contributors in large global trials. Yet, globalization of trials has so many advantages.

    The objective of the session is to gain insight in local/regional conditions with the aim of maximizing quality and efficiently of CV trials and improve generalizability of the results of these trials.

     
    Income inequality and trial performance and outcomes.
    présentation Pooja Dewan (Glasgow, GBR)
     
    Regional Perspectives
     
    • Africa and Middle East:
    présentation Faiez Zannad (Nancy, FRA)
    • Eastern Europe:
    présentation Simon Matskeplishvili (Moscow, RUS)
    • Asia:
    Carolyn Lam (Singapore, SIN)
    présentation              Lijing Yan (Kunshan, CHN)
    • LATAM Countries:
    Felipe Martinez (Cordoba, ARG)
     
    Industry Viewpoint
    Adel Rizkala (Novartis, USA)
    Regulatory Viewpoint
    Robert Temple (FDA, USA)
    Patient Viewpoint
    présentation Stefan Teunis (Oldenzaal, NED)
     
    THE FORUM
    Moderated Multi-Stakeholder ExpertPanel Debate with the Audience
     
    Panelists: Ashraf El Fiky (Washington, USA); Koji Hasegawa (Kyoto, JPN); Larry Husten (CardioBrief, USA); John Jarcho (NEJM, USA); Carolyn Lam (Singapore, SIN); Felipe Martinez (Cordoba, ARG); Simon Matskeplishvili (Moscow, RUS); Manal Milhem (Atlanta, USA); Stuart Spencer (The Lancet, GBR); Lijing Yan (Kunshan, CHN); Faiez Zannad (Nancy, FRA)
     
    AUDITORIUM

    8.00 - 10:00 AM

    PRIMARY AND SECONDARY PREVENTION USING CARDIAC BIOMARKERS (I)
    WILL RESEARCH TRANSLATE INTO IMPROVED OUTCOMES?
     
    Moderators: James Januzzi (Boston, USA), Jean-Claude Tardif (Montreal, CAN)

    Biomarker tests remain the primary diagnostic paradigm with huge potential for innovation and hold the potential to better tailor medications to patients and monitor treatment response. Yet, despite thousands of publications on biomarkers published each year and with these numbers continuously increasing, the anticipated outcome with the transformation of the published findings into improvements in clinical practice is not immediately evident. The vast-majority of blood tests in use currently are decades old and specifically in the cardiovascular space over the past two decades there has been only one new plasma biomarker introduced as a diagnostic test for routine clinical use. To achieve implementation, well-powered clinical studies are required in the appropriate population, addressing a specific clinical need and with a clear context of use.

    Efforts towards implementation must be supported by the key players, i.e. industry, regulators, clinical scientists, sponsors, etc. Patient advocacy groups should lobby stakeholders in order to make CV precision medicine catch up with oncology.

    In addition to discovery studies, well-designed prospective trials should be able to demonstrate the practical value of actionable biomarkers. It is therefore imperative that all major CV outcome trials systematically collect bio-samples. Practice of collecting samples in such industry trials and making little or no use of them should not occur anymore.

    Precision medicine will likely be possible based on multi-marker panels, not on single markers. While the cost of diagnosis/patient assessment may increase, the overall cost and effectiveness of disease management may actually decrease, by avoiding unnecessary exposure to potential non-responders or to patients who might be intolerant to a specific treatment.

    Intellectual property protection of biomarkers already seems impossible, even worse for multi-marker panels. Following the landmark Mayo v. Prometheus, case the US Patent and Trademark Office (USPTO) 2014 guidance denies claims directed to laws of nature, natural phenomena, and abstract ideas. It is under those circumstances that a patent application that aimed to seek IP protection for measuring PCSK9 in plasma to support medical decision-making under various circumstances was rejected. Until the patent law may be challenged, specific algorithms, and trial data that demonstrate significant added value, may confer protection. A large database of multiple parameters together with clinical information and especially follow up may well be the key to IP protection; as long as the database is not shared, this is almost as good, probably even better as IP protection.

    The objective of this session is to discuss the value and validity of recent biomarker findings, assess how little implementation has progressed and discuss how progress may be sought, in the interest of useful innovations and patient care.

     
    • Identifying Subclinical Cardiovascular Disease Using Cardiac Biomarkers: Do We Need to Refine Existing Risk Models? Which Marker Should We Use?
      Torbjorn Omland (Lørenskog, NOR)
     
    How Can Biomarkers Help to Better Understand Cardiovascular Risk?
     
    • In the US Population
    présentation Dan Levy (Boston, USA)
    • In EU Population
    présentation Peter van der Meer (Groningen, NED)
     
    • Multimarker Strategies in the Prediction of MACE in Patients with Known CAD
      Arshed Quyyumi (Atlanta, USA)
    • Multimarker Strategies in the Prediction of New Onset Heart Failure (HOMAGE and other results)
      Faiez Zannad (Nancy, FRA)
    • How can Causal Integrative Analysis of Biomarkers and Genomic Data Inform Therapeutic Approaches in Heart Failure?
      Tom Lumbers (London, GBR)
     
    Recent and Ongoing Biomarker Precision Medicine Trials
     
    • In CAD
    Patrick Lawler (Toronto, CAN)
    • In Heart Failure
    Alexandre Mebazaa (Paris, FRA)
     
    présentation
    • Case: Cohort and Extensive Proteomics for CV Surrogate Endpoint Discovery and Validation
      Stephen Williams (Somalogic, USA)
    présentation
    • Statistician Viewpoint
      Brian Claggett (Boston, USA)
     
    Q & A DISCUSSION
     
    AUDITORIUM

    10:30 AM - 12:30 PM

    PRIMARY AND SECONDARY PREVENTION USING CARDIAC BIOMARKERS (II)
    STAKEHOLDER VIEWPOINT
     
    Moderators: James Januzzi (Boston, USA), Jean-Claude Tardif (Montreal, CAN)
     
    • State of the State in Cardiovascular Diagnostics: Does the Current System Allow Innovation?
      Kristin Pothier (EY-Parthenon, Ernst & Young LLP, Boston, USA)
    • Industry Viewpoint:
      Gillian Murtagh (Abbott Diagnostics, USA); Josh Porter (Olink, USA);
    présentation              André Ziegler (Roche, CHE)
     
    Regulatory Viewpoint: What is it needed to Approve the Clinical Use of a Biomarker?
     
    présentation
    • Qualification Process
      Robert Hemmings (EMA, GBR); Christopher Leptak (FDA, USA)
    présentation
    • Scientific Basis for the Regulatory Adoption
      Norman Stockbridge (FDA, USA)
    • Patient Viewpoint
      Jayna Williams (New Hampshire, USA)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    WHAT IS IT NEEDED TO APPROVE AND USE A NEW BIOMARKER FOR RISK
    PREDICTION AND THERAPEUTIC ACTION IN CLINICAL PRACTICE?
     
    Moderators: James Januzzi (Boston, USA), Jean-Claude Tardif (Montreal, CAN)
     
    Panelists: João Ferreira (Nancy, FRA); Robert Hemmings (EMA, GBR); Anne Cécile Huby (Nancy, FRA); James Januzzi (Boston, USA); Christopher Leptak (FDA, USA); Gillian Murtagh (Abbott Diagnostics, USA); Josh Porter (Olink, USA); Kristin Pothier (EY-Parthenon, Ernst & Young LLP, Boston, USA); Norman Stockbridge (FDA, USA); WH Wilson Tang (Cleveland, USA); Jean-Claude Tardif (Montreal, CAN); Jayna Williams (New Hampshire, USA); André Ziegler (Roche, CHE)
     
    AUDITORIUM
    présentation
    12:40 - 1:10 PM

    KEYNOTE
    Tribute to Ray Lipicky
    Rob Califf (Durham, USA), Milton Packer (Dallas, USA), Robert Temple (FDA, USA)
     
     
    AUDITORIUM

    2:00 - 4:00 PM

    ONGOING HEART FAILURE TRIALS (I)
    LOOKING INTO THE CRYSTAL BALL
    CVCT & HFSA Joint Session
     
    Moderators: Michael Felker (Durham, USA); Christopher O'Connor (Washington, USA)

    Many trials of new therapies for patients with heart failure are ongoing. Trials that demonstrate a benefit on clinical outcomes have the potential to change practice, but the uptake of evidence from clinical trials can be variable, even when the trial has been rigorously conducted and the data are robust. This heterogeneity in uptake can be related to other factors such as cost or delays in payer approval, concerns about adverse effects or polypharmacy, skepticism about the clinical relevance of treatment effects (if they are relatively small), a belief that the study population is not representative, or physician inertia. This session will discuss what may happen in clinical practice depending on hypothetical scenarios and predictions of whether or not ongoing trials will demonstrate a beneficial effect on outcomes

    Discussion on varying scenarios based on prediction of the trial achieving or not its primary result

     
    • With live audience interaction
    • Internet interaction using the App
    • Audience opinion poll pre- and post- debate to determine shift in results
     
    présentation
    • Sacubutril Entresto Trials (PARAGON-HF, PARADISE-MI)
      Scott Solomon (Boston, USA)
    présentation
    • Omecamtiv mecarbil GALACTIC - HF
      John Teerlink (San Francisco, USA)
    présentation
    • Vericiguat VICTORIA
      Paul Armstrong (Edmonton, CAN)
    présentation
    • SGLT2 Inhibitors EMPEROR, DAPA-HF
      Javed Butler (Jacksonville, USA)
    présentation
    • Endothelin Antagonists, the Right Ventricle and HFPEF with Pulmonary Hypertension Trials SERENADE
      Sanjiv Shah (Chicago, USA)
    • Iron Deficiency Trials
      Stefan Anker (Berlin, GER)
    • Mineralocorticoid Receptor Antagonists, SPIRRIT
      Lars Lund (Stockholm, SWE)
    présentation
    • Toresamide
      Robert Mentz (Durham, USA)
    présentation
    • Proposal for a Novel Drug combination of SGLT2 Inhibitor with Torsemide ER for CHF
      Christopher Wilcox (Sarfez Inc, USA)
     
    Q & A DISCUSSION
     
    AUDITORIUM

    4:30 - 7:00 PM

    ONGOING HEART FAILURE TRIALS (II)
    LOOKING INTO THE CRYSTAL BALL
    CVCT & HFSA Joint Session
     
    Moderators: Michael Felker (Durham, USA); Christopher O'Connor (Washington, USA)
     
    présentation
    • Cell Therapy Trials
      Andreas Zeiher (Frankfurt, GER)
    présentation
    • Moving from Phase II to Phase III
      Sanjiv Shah (Chicago, USA)
    présentation
    • Mega Studies in HF - the Good, the Bad and the Unknown: The Serelaxin Case Study
      Beth Davison (Momentum Research, USA)
                   Claudio Gimpelewicz (Novartis, USA)
    • A Statistical Perspective
      Stuart Pocock (London, GBR)
    présentation
    • Device Trials
      William Abraham (Columbus, USA)
    présentation
    • Remote Monitoring and Disease Management Program Trials
      Martin Cowie (London, GBR)
    présentation
    • Biomarker Guided Trials (ICON RELOADED, STRONG HF)
      James Januzzi (Boston, USA)
    présentation
    • The Value (or not) of Using Repeat Events in Heart Failure Trials
      Brian Claggett (Boston, USA)
    présentation
    • Regulatory Viewpoint
      Angeles Alonso (EMA, GBR), Ileana Piña (FDA, USA);
    présentation              Norman Stockbridge (FDA; USA)
    • Patients Viewpoint
      Jillianne Code (Vancouver, CAN)
     
    THE FORUM
    Moderated Multi-Stakeholder Expert Panel Debate with the Audience
    ARE WE PREPARED FOR OPTIMAL IMPLEMENTATION AND MANAGEMENT OF
    POLYPHARMACY IN HF?
     
    Moderators: James Januzzi (Boston, USA), Jean-Claude Tardif (Montreal, CAN)
     
    Panelists: João Ferreira (Nancy, FRA); Robert Hemmings (EMA, GBR); Anne Cécile Huby (Nancy, FRA); James Januzzi (Boston, USA); Christopher Leptak (FDA, USA); Gillian Murtagh (Abbott Diagnostics, USA); Josh Porter (Olink, USA); Kristin Pothier (EY-Parthenon, Ernst & Young LLP, Boston, USA); Norman Stockbridge (FDA, USA); WH Wilson Tang (Cleveland, USA); Jean-Claude Tardif (Montreal, CAN); Jayna Williams (New Hampshire, USA); Andreas Ziegler (Roche, CHE)