title: CHronic use of Amiodarone aGAinSt Implantable cardioverter-defibrillator therapy for primary prevention of death in patients with Chagas cardiomyopathy Study: rationale and design of a randomized clinical trial.
abstract: BACKGROUND
  The implantable cardioverter defibrillator (ICD) is better than antiarrhythmic drug therapy for the primary and secondary prevention of all-cause mortality and sudden cardiac death in patients with either coronary artery disease or idiopathic dilated cardiomyopathy. This study aims to assess whether the ICD also has this effect for primary prevention in chronic Chagas cardiomyopathy (CCC).
  
  
  METHODS
  In this randomized (concealed allocation) open-label trial, we aim to enroll up to 1,100 patients with CCC, a Rassi risk score for death prediction of ≥10 points, and at least 1 episode of nonsustained ventricular tachycardia on a 24-hour Holter monitoring. Patients from 28 centers in Brazil will be randomly assigned in a 1:1 ratio to receive an ICD or amiodarone (600 mg/d for 10 days, then 200-400 mg/d until the end of the study). The randomization sequence will be generated by computer, and the members of the committees responsible for end point validation and data analysis will be blinded to study assignment. The primary end point is all-cause death, and enrolment will continue until 256 patients have reached this end point. Key secondary end points include cardiovascular death, sudden cardiac death, hospitalization for heart failure, and quality of life. We expect follow-up to last 3 to 6 years, and data analysis will be done on an intention-to-treat basis. This trial is registered with ClinicalTrials.gov number NCT01722942.
  
  
  CONCLUSIONS
  CHAGASICS is the first large-scale trial to assess the benefit of ICD therapy for the primary prevention of death in patients with CCC and nonsustained ventricular tachycardia, who have a moderate to high risk of death.
authors.affiliation: Pacemaker Clinic, Instituto do Coração (InCor), Universidade de São Paulo, São Paulo, Brazil. Electronic address: martino@incor.usp.br.
authors.forename: Martino
authors.initials: M
authors.lastname: Martinelli
authors.forename: Anis
authors.initials: A
authors.lastname: Rassi
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Marin-Neto
authors.forename: Angelo Amato Vincenzo
authors.initials: AA
authors.lastname: de Paola
authors.forename: Otávio
authors.initials: O
authors.lastname: Berwanger
authors.forename: Maurício Ibraim
authors.initials: MI
authors.lastname: Scanavacca
authors.forename: Roberto
authors.initials: R
authors.lastname: Kalil
authors.forename: Sérgio Freitas
authors.initials: SF
authors.lastname: de Siqueira
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000638:Amiodarone / Q000627:therapeutic use*; D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use*; D001938:Brazil; D002598:Chagas Cardiomyopathy / Q000150:complications / Q000628:therapy*; D016757:Death, Sudden, Cardiac / Q000209:etiology / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011322:Primary Prevention / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000889:Anti-Arrhythmia Agents; D000638:Amiodarone