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

• Status: Recruiting
• Trial end date: 2022-07-31
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective is to compare the efficacy of the treatment using implantable cardioverter defibrillator (ICD) implantation to that of the treatment using amiodarone in the primary prevention of all-cause mortality in high-risk patients with Chagas cardiomyopathy and non-sustained ventricular tachycardia (NSVT).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InCor Heart Institute
• Collaborators: Abbott Medical Devices; Fundação de Amparo à Pesquisa do Estado de São Paulo; Ministry of Health, Brazil; St. Jude Medical
• Treatments: Amiodarone

Criteria

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 at least two different tests (indirect hemagglutination, indirect immunofluorescence, or ELISA);

• 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 successive beats and duration < 30 seconds, with HR > 120 bpm is mandatory.

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.