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. CONCLUSION: 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.
RCT Entities:
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. CONCLUSION: 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: Rosália Morais Torres; Dalmo Correia; Maria do Carmo Pereira Nunes; Walderez O Dutra; André Talvani; Andréa Silvestre Sousa; Fernanda de Souza Nogueira Sardinha Mendes; Maurício Ibrahim Scanavacca; Cristiano Pisani; Maria da Consolação Vieira Moreira; Dilma do Socorro Moraes de Souza; Wilson de Oliveira Junior; Silvia Marinho Martins; João Carlos Pinto Dias Journal: Mem Inst Oswaldo Cruz Date: 2022-06-06 Impact factor: 2.747
Authors: Antonia Pino-Marín; Germán José Medina-Rincón; Sebastian Gallo-Bernal; Alejandro Duran-Crane; Álvaro Ignacio Arango Duque; María Juliana Rodríguez; Ramón Medina-Mur; Frida T Manrique; Julian F Forero; Hector M Medina Journal: Pathogens Date: 2021-04-22
Authors: David Santacruz; Fernando Rosas; Carina Abigail Hardy; Diego Ospina; Andrea Nathalie Rosas; Juan Manuel Camargo; Juan José Bermúdez; Juan Felipe Betancourt; Víctor Manuel Velasco; Mario D González Journal: Heart Rhythm O2 Date: 2021-12-17
Authors: Tereza Augusta Grillo; Guilherme Rafael S Athayde; Ana Flávia L Belfort; Reynaldo C Miranda; Andrea Z Beaton; Bruno R Nascimento Journal: Case Rep Cardiol Date: 2015-11-08