Status: Finalised First registered on: 13/04/2012
Last updated on: 25/08/2017
1. Study identification
EU PAS Register NumberEUPAS2361
Official titleArrhythmogenic Potential of Drugs
Study title acronymARITMO
Study typeObservational study
Brief description of the studyCardiac ventricular arrhythmia as a side effect of anti-arrhythmic and non-antiarrhythmic drugs has become a major pharmacological safety concern for the pharmaceutical industry and the health regulatory authorities. The overall objective of the ARITMO project is to analyse the ventricular arrhythmogenic potential of individual drugs belonging to the following classes (> 400 compounds): antipsychotics (ATC - Anatomical Therapeutic Chemical classification: N05A), anti-infectives (antibacterials (J01), antimycotics (J02), antivirals (J05), and antiprotozoals (P01)) and H1-antihistamines (R06). The aim of observational database study is to investigate the pro-arrhitmic risk associated to the medications belonging to the following classes: anti-infectives, antihistamines and antipsychotics. In detail, the primary objective is to estimate the rates and relative risks of (a) ventricular arrhythmia (VA) and (b) sudden unexpected death (SUD)/sudden cardiac death (SCD) associated with the most frequently prescribed individual anti-infectives, antihistamines and antipsychotics. To estimate the comparative risks of the study drugs, different comparators will be selected for each drug class of interest. Secondary objectives of the study are: - to explore the effect of dose and duration of use and route of administration on the association between study outcomes and drugs of interest; - to identify demographic and clinical predictors for the specific drug-induced arrhythmias - to describe the prescribing pattern of the study drugs in different databases For each of the two outcomes (VA and SCD/SUD) matched, nested case control studies will be conducted separately to assess the rates and the relative risk associated with anti-infectives, antihistamines and antipsychotics. As regard the anti-infectives, different case control subsets will be created for each drug subgroup (i.e. antibiotics, antivirals, antimycotics and antiprotozoals).
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsErasmus MC Pharmacoepi
Department/Research groupPharmacoepidemiology Erasmus University
Organisation/affiliationErasmus University Medical Center
Website/Homepagewww.erasmusmc.nl
Details of (Primary) lead investigator
Title Professor
Last name Sturkenboom
First name Miriam
Is this study being carried out with the collaboration of a research network?
Yes
ARITMO-Consortium
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?10

PHARMO Institute
UNIBO
Health Search-SIMG
Erasmus MC Pharmacoepi
AARHUS university, Denmark
Uni-HB, Germany
Countries in which this study is being conducted
International study

Denmark
Germany
Italy
Netherlands
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed04/01/201004/01/2010
Start date of data collection01/01/199601/01/1997
Start date of data analysis04/01/201004/01/2010
Date of interim report, if expected
Date of final study report30/09/201308/08/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding schemeSeventh Framework Programme100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Trifiro
First name Gianluca
Address line 1POBOX 2040
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000CA 
CountryNetherlands
Phone number (incl. country code)39-090-2213264 
Alternative phone number31-10-7044123 
Fax number (incl. country code) 
Email address g.trifiro@erasmusmc.nl
Public Enquiries
Title Professor 
Last name Sturkenboom 
First name Miriam 
Address line 1POBOX 2040 
Address line 2dep. Medical Informatics 
Address line 3 
CityRotterdam 
Postcode3000 CA 
CountryNetherlands 
Phone number (incl. country code)31-10-7044123 
Alternative phone number 
Fax number (incl. country code) 
Email address mcjm.sturkenboom@gmail.com 
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