Objective The ability of some compounds to prolong the QT interval of the electrocardiogram and to precipitate Torsade de Pointes (TdP, a potentially fatal arrhythmia) has caused several regulatory interventions, including drug withdrawals. Specific guidelines have been implemented to detect QT liability of new compounds as early as possible. However there is growing evidence that an increase in the QT interval does not necessarily lead to TdP which further increased the regulatory and clinical difficulties. This proposal will assess the arrhythmogenic potential of antipsychotics, antihistamines and anti-infectives (> 250 compounds). It will fulfill this aim by: reviewing the literature on in-vitro and in-vivo preclinical evidence; conducting in-silico modeling to predict the arrhythmic potential through target profiling and docking molecules in existing atomistic models and predicting the effects on hERG K+, Na+, Ca++ channels; analyzing the information in national and international pharmacovigilance DBs of spontaneous reports; conducting prospective case control surveillance on symptomatic QT prolongation; conducting cohort studies in psychiatric and hematology patients; analyzing information from existing studies to assess the association between drug use and various arrhythmia outcomes; and collecting blood samples from cases and drug-matched controls to investigate potential effect modification by candidate genes and a hypothesis generating approach including more than 2000 genes. Healthcare DBs on 27 million persons in 5 countries will be used to calculate rates and relative risks of arrhythmic events during drug use. Predictions on arrhythmic potential will be compared with actual postmarketing risk to assess the predictive value of preclinical markers. All information will be integrated to allow for ranking the arrhythmic potential of all the 250 study drugs and creation of risk charts that will allow for more informed treatment and decision making. Fields of science medical and health sciencesclinical medicinecardiologycardiovascular diseasescardiac arrhythmiamedical and health sciencesclinical medicinehematology Programme(s) FP7-HEALTH - Specific Programme "Cooperation": Health Topic(s) HEALTH-2009-4.2-2 - Study of the Arrhythmogenic potential of different classes of medicines Call for proposal FP7-HEALTH-2009-single-stage See other projects for this call Funding Scheme CP-FP - Small or medium-scale focused research project Coordinator ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM EU contribution € 537 804,00 Address Dr molewaterplein 40 3015 GD Rotterdam Netherlands See on map Region West-Nederland Zuid-Holland Groot-Rijnmond Activity type Higher or Secondary Education Establishments Administrative Contact Miriam Cjm Sturkenboom (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Participants (19) Sort alphabetically Sort by EU Contribution Expand all Collapse all FUNDACIO INSTITUT HOSPITAL DEL MAR D INVESTIGACIONS MEDIQUES Spain EU contribution € 194 974,00 Address Doctor aiguader 88 08003 Barcelona See on map Region Este Cataluña Barcelona Activity type Research Organisations Administrative Contact Andreu Fort (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE ROYAL CHARTER United Kingdom EU contribution € 148 600,00 Address Keppel street WC1E 7HT London See on map Region London Inner London — West Camden and City of London Activity type Higher or Secondary Education Establishments Administrative Contact Penny Ireland (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ALMA MATER STUDIORUM - UNIVERSITA DI BOLOGNA Italy EU contribution € 272 470,00 Address Via zamboni 33 40126 Bologna See on map Region Nord-Est Emilia-Romagna Bologna Activity type Higher or Secondary Education Establishments Administrative Contact Verdiana Bandini (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITAET BREMEN Participation ended Germany EU contribution € 83 614,78 Address Bibliothekstrasse 1 28359 Bremen See on map Region Bremen Bremen Bremen, Kreisfreie Stadt Activity type Higher or Secondary Education Establishments Administrative Contact Sven Petersen (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITY OF NEWCASTLE UPON TYNE United Kingdom EU contribution € 157 800,00 Address Kings gate NE1 7RU Newcastle upon tyne See on map Region North East (England) Northumberland and Tyne and Wear Tyneside Activity type Higher or Secondary Education Establishments Administrative Contact Aleona Blinova (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITE VICTOR SEGALEN BORDEAUX II France EU contribution € 120 780,00 Address Rue leo saignat 146 33076 Bordeaux cedex See on map Activity type Higher or Secondary Education Establishments Administrative Contact Nicholas Moore (Prof.) Links Contact the organisation Opens in new window Total cost No data FONDAZIONE SALVATORE MAUGERI CLINICA DEL LAVORO E DELLA RIABILITAZIONE Italy EU contribution € 48 960,00 Address Via salvatore maugeri 4 27100 Pavia See on map Activity type Research Organisations Administrative Contact Silvia Giuliana Priori (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data CHARITE - UNIVERSITAETSMEDIZIN BERLIN Germany EU contribution € 97 440,00 Address Chariteplatz 1 10117 Berlin See on map Region Berlin Berlin Berlin Activity type Higher or Secondary Education Establishments Administrative Contact Wilhelm Haverkamp (Prof.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data UNIVERSITA DEGLI STUDI DI VERONA Italy EU contribution € 54 720,00 Address Via dell artigliere 8 37129 Verona See on map Region Nord-Est Veneto Verona Activity type Higher or Secondary Education Establishments Administrative Contact Susanna Montalto (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ST GEORGE'S HOSPITAL MEDICAL SCHOOL United Kingdom EU contribution € 293 200,00 Address Cranmer terrace SW17 0RE London See on map Region London Inner London — West Wandsworth Activity type Higher or Secondary Education Establishments Administrative Contact Paul Craven (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ASTRAZENECA AB Sweden EU contribution € 101 465,00 Address Vastra maelarhamnen 151 85 Sodertaelje See on map Region Östra Sverige Stockholm Stockholms län Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Scott Boyer (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Stichting Informatievoorziening voor Zorg en Onderzoek Netherlands EU contribution € 84 600,00 Address Van deventerlaan 3528AE Utrecht See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Ron Mc Herings (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Fondazione Scientifica SIMG-ONLUS Italy EU contribution € 50 400,00 Address Via del pignoncino 9-11 50142 Firenze See on map Activity type Research Organisations Administrative Contact Mazzaglia Giampiero (Dr.) Links Contact the organisation Opens in new window Total cost No data AARHUS UNIVERSITETSHOSPITAL Denmark EU contribution € 84 600,00 Address Palle juul-jensens boulevard 99 8200 Aarhus See on map Region Danmark Midtjylland Østjylland Activity type Research Organisations Administrative Contact Jesper Dambo Nielsen (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data ACADEMISCH MEDISCH CENTRUM BIJ DE UNIVERSITEIT VAN AMSTERDAM Netherlands EU contribution € 52 800,00 Address Meibergdreef 15 1105AZ Amsterdam See on map Region West-Nederland Noord-Holland Groot-Amsterdam Activity type Higher or Secondary Education Establishments Administrative Contact Hanno L. Tan (Dr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data Drug Safety Research Trust United Kingdom EU contribution € 217 600,00 Address Blundell lane, bursledon hal SO31 1AA Southampton See on map Activity type Research Organisations Administrative Contact Chris Atkinson (Mr.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data LEIBNIZ-INSTITUT FUR PRAVENTIONSFORSCHUNG UND EPIDEMIOLOGIE - BIPS GMBH Germany EU contribution € 65 905,22 Address Achterstrasse 30 28359 Bremen See on map Region Bremen Bremen Bremen, Kreisfreie Stadt Activity type Other Administrative Contact Xiaogang Gerns Links Contact the organisation Opens in new window Website Opens in new window Total cost No data SYNAPSE RESEARCH MANAGEMENT PARTNERS SL Spain EU contribution € 80 586,00 Address Calle velazquez 94 planta 1 28006 Madrid See on map Region Comunidad de Madrid Comunidad de Madrid Madrid Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Eva Molero (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data PHARMO Institute N.V. Netherlands EU contribution No data Address Van deventerlaan 30-40 3528 AE Utrecht See on map Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Administrative Contact Heleen Van Engeland (Ms.) Links Contact the organisation Opens in new window Website Opens in new window Total cost No data