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

Inclusion Criteria:

• Written informed consent prior to randomization and any study procedure;
• Both genders, age > 18 years and < 75 years;
• Recent (previous 6 months) documented positive serologic test for Chagas disease in atleast two different tests (indirect hemagglutination, indirect immunofluorescence, orELISA);
• Presence of at least 10 points in Rassi risk score for death prediction;
• Presence of at least 1 episode of NSVT on Holter monitoring, defined as > 3 successivebeats and duration < 30 seconds, with HR > 120 bpm is mandatory.

Exclusion Criteria:

• Participation in another study currently or < 1 year ago, except for totally unrelatedobservational 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 portalhypertension 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 (includingNYHA class IV CHF);
• Pregnancy or breastfeeding;
• Childbearing potential during the study (non-menopausal patients who have notundergone 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 degreeatrioventricular block (AV) block; Complete AV block; QTc > 500mseg;
• Formal indication for the use of amiodarone or defibrillator (NSVT and very disturbingpalpitations, presyncope or syncope; SVT; recovery from cardiac arrest);
• Use of amiodarone in the past 6 months, except if started for < 2 weeks and if loadingdose 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 ofamiodarone;
• Persistent or permanent atrial fibrillation;
• Previous withdrawal from this study.