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dc.contributorSistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP-
dc.contributor.authorMARTINELLI, Martino-
dc.contributor.authorRASSI JR., Anis-
dc.contributor.authorMARIN-NETO, Jose Antonio-
dc.contributor.authorPAOLA, Angelo Amato Vincenzo de-
dc.contributor.authorBERWANGER, Otavio-
dc.contributor.authorSCANAVACCA, Mauricio Ibraim-
dc.contributor.authorKALIL, Roberto-
dc.contributor.authorSIQUEIRA, Sergio Freitas de-
dc.identifier.citationAMERICAN HEART JOURNAL, v.166, n.6, p.976-U69, 2013-
dc.description.abstractBackground 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 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.-
dc.description.sponsorshipSt Jude-
dc.relation.ispartofAmerican Heart Journal-
dc.subject.otherventricular systolic dysfunction-
dc.subject.otherremadhe prospective trial-
dc.subject.otherbeta-blocker therapy-
dc.subject.otherlow-dose amiodarone-
dc.subject.othersecondary prevention-
dc.subject.otherpredicting death-
dc.subject.otherrisk score-
dc.titleCHronic 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-
dc.rights.holderCopyright MOSBY-ELSEVIER-
dc.contributor.groupauthorCHAGASICS Investigators-
dc.subject.wosCardiac & Cardiovascular Systems-
dc.type.categoryoriginal article-
dc.type.versionpublishedVersion- JR., Anis:Anis Rassi Hosp, Div Cardiol, Goiania, Go, Brazil-, Jose Antonio:Univ Sao Paulo, Div Cardiol, Fac Med Ribeirao Preto, Sao Paulo, Brazil-, Angelo Amato Vincenzo de:Escola Paulista Med UNIFESP, Div Cardiol, Sao Paulo, Brazil-, Otavio:Res Inst HCor Hosp Coracao, Sao Paulo, Brazil-
hcfmusp.publisher.cityNEW YORK-
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Appears in Collections:

Artigos e Materiais de Revistas Científicas - FM/MCP
Departamento de Cardio-Pneumologia - FM/MCP

Artigos e Materiais de Revistas Científicas - HC/InCor
Instituto do Coração - HC/InCor

Artigos e Materiais de Revistas Científicas - LIM/11
LIM/11 - Laboratório de Cirurgia Cardiovascular e Fisiopatologia da Circulação

Artigos e Materiais de Revistas Científicas - ODS/03
ODS/03 - Saúde e bem-estar

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