Li Shen1, Felix Ramires1, Felipe Martinez1, Luiz Carlos Bodanese1, Luis Eduardo Echeverría1, Efraín A Gómez1, William T Abraham1, Kenneth Dickstein1, Lars Køber1, Milton Packer1, Jean L Rouleau1, Scott D Solomon1, Karl Swedberg1, Michael R Zile1, Pardeep S Jhund1, Claudio R Gimpelewicz1, John J V McMurray2. 1. From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (L.S., P.S.J., J.J.V.M.); Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil (F.R.); Instituto DAMIC/Fundacion Rusculleda, Cordoba, Argentina (F.M.); Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (L.C.B.); Grupo de Ciencias Cardiovasculares, Fundación Cardiovascular de Colombia, Santander (L.E.E.); Clinica Shaio, Bogota, Colombia (E.A.G.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.T.A.); Stavanger University Hospital, University of Bergen, Norway (K.D.); Rigshospitalet Copenhagen University Hospital, Denmark (L.K.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.L.R.); Cardiovascular Medicine, Brigham and Women's Hospital, Boston MA (S.D.S.); Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.); National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.); Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston (M.R.Z.); and Novartis Pharma, Basel, Switzerland (C.R.G.). 2. From the BHF Cardiovascular Research Centre, University of Glasgow, United Kingdom (L.S., P.S.J., J.J.V.M.); Instituto do Coração (InCor) do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Brazil (F.R.); Instituto DAMIC/Fundacion Rusculleda, Cordoba, Argentina (F.M.); Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil (L.C.B.); Grupo de Ciencias Cardiovasculares, Fundación Cardiovascular de Colombia, Santander (L.E.E.); Clinica Shaio, Bogota, Colombia (E.A.G.); Division of Cardiovascular Medicine, Davis Heart and Lung Research Institute, Ohio State University, Columbus (W.T.A.); Stavanger University Hospital, University of Bergen, Norway (K.D.); Rigshospitalet Copenhagen University Hospital, Denmark (L.K.); Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.); Institut de Cardiologie de Montréal, Université de Montréal, Canada (J.L.R.); Cardiovascular Medicine, Brigham and Women's Hospital, Boston MA (S.D.S.); Department of Molecular and Clinical Medicine, University of Gothenburg, Sweden (K.S.); National Heart and Lung Institute, Imperial College, London, United Kingdom (K.S.); Medical University of South Carolina and Ralph H. Johnson Veterans Administration Medical Center, Charleston (M.R.Z.); and Novartis Pharma, Basel, Switzerland (C.R.G.). john.mcmurray@glasgow.ac.uk.
Abstract
BACKGROUND: Chagas' disease is an important cause of cardiomyopathy in Latin America. We aimed to compare clinical characteristics and outcomes in patients with heart failure (HF) with reduced ejection fraction caused by Chagas' disease, with other etiologies, in the era of modern HF therapies. METHODS AND RESULTS: This study included 2552 Latin American patients randomized in the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and ATMOSPHERE (Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure) trials. The investigator-reported etiology was categorized as Chagasic, other nonischemic, or ischemic cardiomyopathy. The outcomes of interest included the composite of cardiovascular death or HF hospitalization and its components and death from any cause. Unadjusted and adjusted Cox proportional hazards models were performed to compare outcomes by pathogenesis. There were 195 patients with Chagasic HF with reduced ejection fraction, 1300 with other nonischemic cardiomyopathy, and 1057 with ischemic cardiomyopathy. Compared with other etiologies, Chagasic patients were more often female, younger, and had lower prevalence of hypertension, diabetes mellitus, and renal impairment (but had higher prevalence of stroke and pacemaker implantation) and had worse health-related quality of life. The rates of the composite outcome were 17.2, 12.5, and 11.4 per 100 person-years for Chagasic, other nonischemic, and ischemic patients, respectively-adjusted hazard ratio for Chagasic versus other nonischemic: 1.49 (95% confidence interval, 1.15-1.94; P=0.003) and Chagasic versus ischemic: 1.55 (1.18-2.04; P=0.002). The rates of all-cause mortality were also higher. CONCLUSIONS: Despite younger age, less comorbidity, and comprehensive use of conventional HF therapies, patients with Chagasic HF with reduced ejection fraction continue to have worse quality of life and higher hospitalization and mortality rates compared with other etiologies. CLINICAL TRIAL REGISTRATION: PARADIGM-HF: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255; ATMOSPHERE: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00853658.
RCT Entities:
BACKGROUND:Chagas' disease is an important cause of cardiomyopathy in Latin America. We aimed to compare clinical characteristics and outcomes in patients with heart failure (HF) with reduced ejection fraction caused by Chagas' disease, with other etiologies, in the era of modern HF therapies. METHODS AND RESULTS: This study included 2552 Latin American patients randomized in the PARADIGM-HF (Prospective Comparison of ARNI With ACEI to Determine Impact on Global Mortality and Morbidity in Heart Failure) and ATMOSPHERE (Aliskiren Trial to Minimize Outcomes in Patients With Heart Failure) trials. The investigator-reported etiology was categorized as Chagasic, other nonischemic, or ischemic cardiomyopathy. The outcomes of interest included the composite of cardiovascular death or HF hospitalization and its components and death from any cause. Unadjusted and adjusted Cox proportional hazards models were performed to compare outcomes by pathogenesis. There were 195 patients with Chagasic HF with reduced ejection fraction, 1300 with other nonischemic cardiomyopathy, and 1057 with ischemic cardiomyopathy. Compared with other etiologies, Chagasic patients were more often female, younger, and had lower prevalence of hypertension, diabetes mellitus, and renal impairment (but had higher prevalence of stroke and pacemaker implantation) and had worse health-related quality of life. The rates of the composite outcome were 17.2, 12.5, and 11.4 per 100 person-years for Chagasic, other nonischemic, and ischemicpatients, respectively-adjusted hazard ratio for Chagasic versus other nonischemic: 1.49 (95% confidence interval, 1.15-1.94; P=0.003) and Chagasic versus ischemic: 1.55 (1.18-2.04; P=0.002). The rates of all-cause mortality were also higher. CONCLUSIONS: Despite younger age, less comorbidity, and comprehensive use of conventional HF therapies, patients with Chagasic HF with reduced ejection fraction continue to have worse quality of life and higher hospitalization and mortality rates compared with other etiologies. CLINICAL TRIAL REGISTRATION: PARADIGM-HF: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01035255; ATMOSPHERE: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00853658.
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