Amiodarone Against ICD Therapy in Chagas Cardiomyopathy for Primary Prevention of Death

Exclusion Criteria

• •Participation in another study currently or \< 1 year ago, except for totally unrelated observational studies;
• •Other concomitant cardiovascular disease, including uncontrolled diabetes mellitus (systemic hypertension without target-organ impairment is allowed);
• •Renal dysfunction (serum creatinine \> 1.5 mg/dL or glomerular filtration rate (GFR) \< 60 mL/min/1.73m2) or liver dysfunction with diagnosis of cirrhosis or portal hypertension or elevated serum enzymes (AST or ALT) \> 3 x the upper normal limit;
• •Moderate or severe chronic obstructive pulmonary disease;
• •Peripheral polyneuropathy;
• •Hypo or hyper-thyroidism;
• •Current alcoholism or quit for \<2 years;
• •Mental disorder or illicit drug addiction;
• •Life expectancy \< 1 year, because of the disease itself or of comorbidities (including NYHA class IV CHF);
• •Pregnancy or breastfeeding;
• •Childbearing potential during the study (non-menopausal patients who have not undergone a safe and permanent birth control method);
• •Other contraindications for the use of amiodarone: previous intolerance to the drug; HR \< 55bpm; sinus node disease; type II Mobitz; fixed 2:1 AV block; advanced degree atrioventricular block (AV) block; Complete AV block; QTc \> 500mseg;
• •Formal indication for the use of amiodarone or defibrillator (NSVT and very disturbing palpitations, presyncope or syncope; SVT; recovery from cardiac arrest);
• •Use of amiodarone in the past 6 months, except if started for \< 2 weeks and if loading dose had been \<10g and maintenance dose ≤100mg/day;
• •Current use of betablocker considered clinically indispensable, with bradycardia \< 55/min or AV block ≥ 1st degree, without pacemaker implantation;
• •Current use of other medications with contraindication to the concomitant use of amiodarone;
• •Persistent or permanent atrial fibrillation;
• •Previous withdrawal from this study.