Title
Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.
A Randomised Double-blind Pilot Study Comparing Flecainide CR and Placebo in the Early Treatment of Patients With a Documented First Episode of Atrial Fibrillation.
Phase
Phase 4Lead Sponsor
MedaStudy Type
InterventionalStatus
TerminatedIndication/Condition
Atrial FibrillationIntervention/Treatment
flecainide ...Study Participants
256The purpose of the study is to assess the efficacy of flecainide controlled release (CR) in the prevention of recurrent AF during 9 months of active treatment compared to placebo in patients with only one documented AF episode.
Inclusion Criteria: History of first symptomatic & documented episode of AF LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment Exclusion Criteria: History of more than 1 symptomatic documented AF episode, persistent or permanent AF. History of ablation for previous AF Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery Severe symptoms during AF episode (e.g.syncope, chest pain) All types of treated arrhythmias other than AF History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases Left ventricular ejection fraction (LVEF) ≤ 40% Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms Brugada syndrome Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block 2nd or 3rd degree atrioventricular (AV) block Sinus node dysfunction Severe hypertension with:Systolic blood pressure ≥ 180 mmHg, and / or· Diastolic blood pressure ≥ 100 mmHg Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram Implanted pacemaker Heart surgery within the last 6 months, or non-stable postoperative condition Renal failure: serum creatinine ≥ 150 µmol/l or creatinine clearance ≤ 50 ml/min (Cockroft and Gault formula Uncorrected electrolytic abnormalities Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB