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
| Autor: | Martinelli, Martino, Rassi, Anis, Antonio Marin-Neto, Jose, Paola, Angelo Amato Vincenzo de [UNIFESP], Berwanger, Otavio, Scanavacca, Mauricio Ibraim, Kalil, Roberto, Siqueira, Sergio Freitas de, CHAGASICS Investigators |
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| Přispěvatelé: | Universidade de São Paulo (USP), Anis Rassi Hosp, Universidade Federal de São Paulo (UNIFESP), Res Inst HCor Hosp Coracao |
| Jazyk: | angličtina |
| Rok vydání: | 2013 |
| Předmět: |
Adult
Chagas Cardiomyopathy Male medicine.medical_specialty Adolescent medicine.medical_treatment Amiodarone Ventricular tachycardia law.invention Sudden cardiac death Young Adult Randomized controlled trial law Internal medicine Idiopathic dilated cardiomyopathy Medicine Humans Aged Framingham Risk Score business.industry DISPOSITIVO DE ASSISTÊNCIA CIRCULATÓRIA Middle Aged Implantable cardioverter-defibrillator medicine.disease Defibrillators Implantable Primary Prevention Death Sudden Cardiac Treatment Outcome Heart failure Cardiology Female Cardiology and Cardiovascular Medicine business Anti-Arrhythmia Agents Brazil medicine.drug |
| Zdroj: | Repositório Institucional da UNIFESP Universidade Federal de São Paulo (UNIFESP) instacron:UNIFESP Repositório Institucional da USP (Biblioteca Digital da Produção Intelectual) Universidade de São Paulo (USP) instacron:USP |
| Popis: | St Jude 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. Univ São Paulo, Pacemaker Clin, Inst Coracao InCor, São Paulo, Brazil Anis Rassi Hosp, Div Cardiol, Goiania, Go, Brazil Univ São Paulo, Div Cardiol, Fac Med Ribeirao Preto, São Paulo, Brazil Escola Paulista Med UNIFESP, Div Cardiol, São Paulo, Brazil Res Inst HCor Hosp Coracao, São Paulo, Brazil Univ São Paulo, Arrhythmia Clin, Inst Coracao InCor, São Paulo, Brazil Univ São Paulo, Inst Coracao InCor, São Paulo, Brazil Escola Paulista Med UNIFESP, Div Cardiol, São Paulo, Brazil Web of Science |
| Databáze: | OpenAIRE |
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