Comparative Study of Flecainide CR and Placebo in the Early Treatment of Atrial Fibrillation.

Study Overview
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Brief Summary
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The 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.

Official Title
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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.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Drug: Flecainide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Flecainide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to the first relapse after randomization, with or without symptoms documented on ECG, Holter or Self ECG unit recording. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total number of AF recurrences during the treatment period |  |  | 
| Total number of patients in sinus rhythm at the end of the study |  |  | 
| AF Burden |  |  | 
| Number of emergency admissions due to AF recurrence |  |  | 
| Cardiac Safety |  |  |