Cardiovascular Conference Cardiovascular Conference h 20 2h 20 215 March 201215 March 2012

Cardiovascular Innovation & Research in the NetherlandsVRN and WCN – the next 5 years

Arend Mosterd

Working group Cardiovascular research g g pthe Netherlands

• Background

– Independent network started in 1988

– 60 cardiology clinics (non academic)

• Past and present

• Future

WCN sites

Aims of the WCNAims of the WCN

• Initiation and execution of scientific research S pport member sites in doing so• Support member sites in doing so – GCP guidelines & standard operating procedures (SOP)

• Organisation of (study) meetings & conferences

• Ultimate goal– Change the guidelines to improve patient care Change the guidelines to improve patient care

Research proposalp pIndustry, university, ‘own’ study

Evaluation of proposalBoard and bureau/office

FeasibilityMember questionnaire

Selection of centersSelection of centers“Commission Indeling Centra”

WCN study director

W C N m e m b e r O ff ic e W C N G e n e ra l B o a rd W C N

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Mail partic ipation

11Start

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Allocation of studiesAllocation of studies

• CIC committee (Commissie Indeling Centra)

- 3 WCN members - Track record Track record - Area of interest - Competing trials - Competing trials - Resources

WCN study directoryspider in the web

• Liason with initiators of study

• Liason with participating WCN sites• Liason with participating WCN sites

• Report to WCN office / board

Working group Cardiovascular research g g pthe Netherlands

• Background

• Past and present• Past and present

• Future• Future

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AFRODITE x x x x x x x x x x x x x x x x x x x x x x xARISTOTLE x x x x x x x x x x xARISTOTLE x x x x x x x x x x xaSTAIRe x x x xAVRO x x x x xBOREALIS x x x x x x x x x x x x xPALLAS x x x x x x x x x x x x x x x x x x x x x x x x x x xRACE II x x x x x x x x x x x x x x x x x x x x x x x x x xRACE III x x x x x x x x x x x x x xRE-LY x x x x x x x x x x x x x x x x x x x x xRE LY x x x x x x x x x x x x x x x x x x x x xRELYABLE x x x x x x x x x x x x x x x x x x x x xROCKET AF x x x x x x x x x x x x x x xVERNAKALANT i.v. x x x x x x xASCEND x x x x xATMOSPHERE x x x x x x x x x xCOZAAR HEAAL x x x x x x x x xEMPHASIS x x x x x x x x xParamount x x x x x xParadigm x x x x x x x x x x x x x x x x xRED - HF x x x x x x x x x x x xRELAX x x x x x x xSHIFT x x x x x x x x x x x x x x x x x x x x x x x x x x x xWARCEF x x x x x x x x x xTIMI 50 TRA-2P x x x x x x x x x x x x x x x x x x x x x x x xSSTABILITY x x x x x x x x x x xAPPRAISE II x x x x x x x x x x x xATLAS II TIMI 51 x x x x x x x x x x x xAXIOM, Takeda x x x x xBIOMARCS x x x x x x x x x x x x xDal-OUTCOMES x x x x X x x x x x x x x x x x x x x x x x x x x xEPICOR x x x x x x x x x x x xIMPROVE IT x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xIMPROVE- IT x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xPEGASUS TIMI 54 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xRUBY I x x x x x x x xSOLID TIMI 52 x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xTRACER x x x x x x x x x x x x x x xTRILOGY x x x x x x x x x x x x x x x xVISTA 16 x x x x x x x x x x x x x x x xSIGNIFY x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xSIGNIFY x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x x xCAROLINA x x xELIXA x x x xORIGIN x x x x x x x x x x x x x x xSAVOR TIMI 53 x x x x x x x x x x x x x xTIDE x x x x

Working group Cardiovascular research g g pthe Netherlands 2004 -2010

# pts per CV indication 2004-2010(total # pts 13,361)

2726

1909

2899

1532504

4159

434197

ACS Atrial Fibrillation DM II/ CV preventieHeart Failure Lipid trials PacingHeart Failure Lipid trials PacingPreventie Registry stable AP/postACS

Working group Cardiovascular research g g pthe Netherlands 2011

Working group Cardiovascular research g g pthe Netherlands – some contributions

• Heart failure– Ascend

• Atrial fibrillationRELY d RACE t di– RELY and RACE studies

• LipidsLipids– Corona

ASCENDNesiritide in acute heart failure

• Vasodilation

• Sodium excretion

• Inhibition of RAAS

• Inhibition of sympathetic nervous activity

Natrecor!Natrecor!D

R I

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• Identical to the endogenous human B-type natriuretic peptide (hBNP)

K

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• Manufactured from E. Coli using recombinant DNA technology

GSGQVMKPS

technology

• Endogenous BNP:g– is produced mainly in the ventricular wall– role in normal sodium / water regulation and

cardiac function– levels rise in a compensatory response to elevated

ventricular filling pressures in the failing heartventricular filling pressures in the failing heart

Nesiritide (Natrecor)

Indications and usage“.. Indicated for the i.v. treatment

of patients with acutely decompensated heart failure. In this population the use of this population, the use of Natrecor reduced pcwp and improved dyspnea.”improved dyspnea.

- FDA approved (VMAC trial)FDA approved (VMAC trial)- No European (EMEA) registration

Nesiritide, Not Verified

Nesiritide, Not VerifiedNesiritide, Not Verified

ASCEND – HF(Acute Study of Clinical Effectiveness of Nesiritide in subjects (Acute Study of Clinical Effectiveness of Nesiritide in subjects

with Decompensated Heart failure)

ASCEND – HF(Acute Study of Clinical Effectiveness of Nesiritide in subjects (Acute Study of Clinical Effectiveness of Nesiritide in subjects

with Decompensated Heart failure)

Atrial fibrillationRACE I & IIRACE I & II

Atrial fibrillationRELYRELY

Atrial fibrillationRELYRELY

CORONARosuvastatin in patients with impaired LV systolic function

CORONARosuvastatin in patients with impaired LV systolic function

Working group Cardiovascular research g g pthe Netherlands

• Background

- the proof is in the eating

• Past and present

• Future

Working group on Cardiovascular research The Netherlandsresearch The Netherlands

• Threats:– No farma left in the NetherlandsNo farma left in the Netherlands

– Farma moving away from cv research

– Costs (vis a vis eastern europe)

– Regulation and timelinesg

• Opportunities:– Quality (deliver what you promise)

– Use and combine existing infrastructureUse and combine existing infrastructure

XXV A l S i tifiXXV Annual Scientific WCN CongressWCN Congress

22 – 23 november 2012Beurs van Berlage g

Amsterdam

Working group on Cardiovascular research Th N h l dThe Netherlands

www.wcnweb.nl