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The German Atrial Fibrillation Competence NETwork (AFNET), the European Heart Rhythm Association (EHRA), (a registered branch of the European Society of Cardiology (ESC)), Sanofi Aventis, and St Jude Medical join forces to conduct the EAST (Early comprehensive Atrial fibrillation Stroke prevention Trial) clinical trial. This investigator-initiated study seeks to determine whether an early, comprehensive, standardized intervention program can help prevent adverse cardiovascular outcomes associated with prolonged atrial f ibrillation (AF), including stroke and death. More specifically, the EAST will study whether an early and comprehensive rhythm control therapy of early onset AF produces on top of usual care better patient outcomes than usual care alone.
The sponsor of EAST is AFNET. EHRA is an equal scientific partner in the trial. Sanofi Aventis and St Jude Medical provide funds to support the conduct of the trial. The planned enrolment is more than 3000 patients from 200 centers in Europe, with participating centers from 11 European countries.
AF is a condition in which the upper chambers of the heart (atria) beat rapidly and erratically, affecting the heart’s ability to adequately pump blood to its lower chambers (ventricles) and subsequently to the rest of the body. Some of the complications caused by AF are increased risk of death or stroke, increased severity of stroke, increased hospitalizations, and reduced quality of life due to palpitations and other AF-related symptoms. The disease affects between one and two percent of Europe’s population.
The arrhythmia can have an impact on the heart as early as a few weeks after onset, causing cycles of remodeling, dysfunction and additional triggers which help progress AF. These cycles both maintain and perpetuate AF from the state of initial detection, to paroxysmal (AF that begins suddenly and ends spontaneously) to persistent (recurring episodes lasting more than seven days) to permanent (ongoing and long term).
EAST is a prospective, parallel-group, randomized, open, blinded, end-point assessment trial. The multicenter study seeks to understand how to improve rhythm control therapy in the prevention of death and stroke. Specifically, whether an earlier initiation of rhythm control therapy, when included in a comprehensive AF management strategy, has the potential to maintain the heart’s rhythm more effectively, prevent AF-related complications, and disrupt the cycles that maintain AF and cause complications.
Commenting on the need for the EAST study, Prof. Dr. Paulus Kirchhof, coordinating investigator of the trial said: “The trial is based on the observation that insufficient, non-structured and delayed therapy of the multiple factors that maintain AF and cause its complications has most likely contributed to the limited effectiveness of rhythm control interventions in past trials. This trial takes an important step forward to learn more about the value of rhythm control therapy to improve the lives of AF patients by accounting for the cycles that initiate and maintain the disease and contribute to AF-related complications.”
Patients with recent-onset AF at risk for stroke or death are eligible for the trial. Participants will be randomized to either an “early, comprehensive, standardized” intervention to maintain sinus rhythm on top of usual care, or to “usual care” alone. Early intervention will include antiarrhythmic drug therapy and/or pulmonary vein isolation (PVI) using catheter ablation as well as ECG monitoring of therapy. Usual care follows standardized therapy under the 2010 ESC guidelines for the treatment of AF.
The primary outcome of EAST is the composite of cardiovascular death, stroke and heart failure or acute coronary syndrome (hospitalization). There will be outpatient follow-up at 12, 24 and 36 months. AFNET The German Atrial Fibrillation Network (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 in atrial fibrillation. The network has been funded by the German Federal Ministry of Research and Education since 2003. EHRA The European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology ( ESC) is an association specialising in electrophysiology. Its goal is to serve as the leading organisation in the field of arrhythmias and electrophysiology in Europe, and to attract all physicians from Europe and beyond to foster the development of this area of expertise.
ClinicalTrials.gov: NCT01288352 http://clinicaltrials.gov/ct2/show/NCT01288352?term=NCT01288352&rank=1
ISRCTN: ISRCTN04708680 http://www.controlled-trials.com/ISRCTN04708680/ISRCTN04708680
Angelika Leute, AFNET Angelika.email@example.com
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