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Clinical Research needs investigator initiated trials: AFNET-EAST has enrolled 1000 patients

On 4th November 2013 the 1000th patient was enrolled in the AFNET-EAST trial.

The pan-European clinical trial “Early treatment of atrial fibrillation for stroke prevention trial (EAST)“ conducted by the German association Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.) in cooperation with the European Heart Rhythm Association (EHRA) compares two different treatment strategies in atrial fibrillation. EAST exemplifies the added value of independent investigator initiated trials (IIT) for clinical progress. Many questions which are important for medical care, such as the relevance of early rhythm control therapy, will not be addressed by commercial trials.
Atrial Fibrillation

Several million people in Europe, 1 to 2 percent of the population, suffer from atrial fibrillation. Especially elderly people are affected by this cardiac arrhythmia. The arrhythmia is not directly life-threatening, but it can cause severe complications, for example strokes. While medical progress has markedly reduced mortality of several cardiovascular diseases, for example heart attack, patients with atrial fibrillation still have an increased mortality risk.

EAST trial compares early rhythm control therapy to usual care

The EAST trial evaluates whether an early restoration of the normal (sinus) heart rhythm, in addition to anticoagulation, can prevent complications more effectively than usual care. Since summer 2011, over 1000 of the 2810 scheduled patients have been enrolled in 11 European countries. More than 100 hospitals and practices are participating in patient recruitment.
The study patients are randomized to either receive “early rhythm control therapy” or “usual care”. Usual care is consistent with the therapy recommended by the current guidelines of the European Society of Cardiology (ESC). In the early rhythm control therapy group, this “usual care” is supplemented by every available method needed to stop atrial fibrillation as early as possible and to restore and maintain the normal heart rhythm throughout the study duration.
Prof. Paulus Kirchhof, principal investigator and coordinator of the trial, explained: “Many cardiologists are convinced, as I am, that patients can benefit from the preservation of sinus rhythm. But we do not have data from controlled trials to suggest that rhythm control therapy will help to prevent complications associated with AF. That is why we are conducting the EAST trial. The direct comparison of both treatment concepts will reveal the benefit of maintaining sinus rhythm.”

AFNET e.V. bears overall responsibility of investigator initiated trials

EAST is an investigator initiated trial (IIT). The German association Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.) has initiated the trial in cooperation with the European Heart Rhythm Association (EHRA) and bears the overall responsibility of the trial. The scientific conduct is overseen by an executive steering committee consisting of the cardiologists Prof. Paulus Kirchhof, Birmingham, UK, and Münster, Germany (chair), Prof. Günter Breithardt, Münster, Germany, Prof. John Camm, London, UK, Prof. Harry Crijns, Maastricht, The Netherlands, Professor Karl-Heinz Kuck, Hamburg, Germany, and Professor Panos Vardas, Heraklion, Greece, and the biostatistician Prof. Karl Wegscheider, Hamburg, Germany. For the conduct of the trial, AFNET e.V. relies on financial support that is provided by the companies Sanofi and St. Jude Medical.
The question investigated in the EAST trial arose from clinical practice, as in many investigator initiated trials. The trial only attempts to provide knowledge and is not driven by marketing or approval interests: All drugs and devices used in the trial have been approved and are used within their approved indication. The result will help to optimize care of patients with AF in different health care systems. Patients benefit from the fact that established treatment concepts are continuously being tested and improved by investigator initiated trials.
“Investigator initiated trials are indispensable for medical care. If such independent clinical research did not exist, many important questions would never be investigated. This also includes the comparison of different treatment strategies as performed in the EAST trial.” Prof. Breithardt summarized.
AFNET e.V. has 10 years of experience in the conduct of investigator initiated trials and is therefore well qualified to investigate such clinical questions free from commercial interests. In addition to EAST, further investigator initiated trials and registries are currently in preparation.

Notes to editor

The German Competence Network on Atrial Fibrillation (AFNET) is an interdisciplinary research network located in Germany. AFNET aims at improving care of patients with atrial fibrillation by promoting research, medical services and information in emerging diagnostic and therapeutic fields. The network has been funded by the German Federal Ministry of Research and Education since 2003.
About AFNET association Kompetenznetz Vorhofflimmern e.V.
As the public funding of AFNET isl not in perpetuity, AFNET has founded the association Kompetenznetz Vorhofflimmern e.V. (AFNET e.V.), Münster, Germany, that will continue the network activities in the long term. Kompetenznetz Vorhofflimmern e.V. is the legal sponsor of the EAST trial.
About the European Heart Rhythm Association
The European Heart Rhythm Association (EHRA) is a registered branch of the ESC. Its aim is to improve the quality of life of the European population by reducing the impact of cardiac arrhythmias and reducing sudden cardiac death.