title: Pharmacological interventions for treating heart failure in patients with chagas cardiomyopathy.
abstract: BACKGROUND
  Chagas disease-related cardiomyopathy is a major cause of morbidity and mortality in Latin America. Despite the substantial burden to the healthcare system, there is uncertainty regarding the efficacy and safety of pharmacological interventions for treating heart failure in patients with Chagas disease.
  
  
  OBJECTIVE
  To assess the benefits and harms of current pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy.
  
  
  METHODS
  We searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library) Issue 1, 2011, MEDLINE (Ovid), EMBASE (Ovid), LILACS and ISI Web of Science to April 2011. We checked the reference lists of included papers. No language restrictions were applied.
  
  
  METHODS
  We included randomized clinical trials assessing the effects of pharmacological interventions for treating heart failure in adult patients (≥18 years) with symptomatic heart failure (New York Heart Association class II to IV), irrespective of the left ventricular ejection fraction stage, reduced or preserved, with Chagas cardiomyopathy. No limits were applied with respect to the follow-up duration. Primary outcomes were all-cause mortality, cardiovascular mortality at 30 days, time to heart decompensation and disease-free period (at 30, 60 and 90 days), and adverse events.
  
  
  METHODS
  Two authors independently performed study selection, risk of bias assessment and data extraction. We estimated relative risks (RR) and the respective 95% confidence intervals (CIs) for dichotomous outcomes. We measured statistical heterogeneity using the I(2) statistic. We used a fixed-effect model to synthesize the findings. We contacted authors for additional data.
  
  
  RESULTS
  We included two randomized clinical trials involving 69 participants. Both trials compared carvedilol against placebo, and had a high risk of bias. Carvedilol compared with placebo did not significantly affect all-cause mortality (2/34 (5.88%) versus 3/35 (5.87%); pooled RR 0.69, 95% CI 0.12 to 3.88, I(2) = 0%). None of the trials reported on cardiovascular mortality, time to heart decompensation or disease-free period. Evidence on the adverse effects of carvedilol is inconclusive.
  
  
  CONCLUSIONS
  This Cochrane review has found a lack of evidence on the effects of carvedilol for treating heart failure in patients with Chagas disease. The two included trials were underpowered and had a high risk of bias. There are no conclusive data to support the use of carvedilol for treating Chagas cardiomyopathy. Unless randomized clinical trials provide evidence of a treatment effect, and the trade off between potential benefits and harms is established, policy-makers, clinicians, and academics should be cautious when recommending and administering carvedilol for treating heart failure in patients with Chagas disease. The efficacy and safety of other pharmacological interventions for treating heart failure in patients with Chagas disease is unknown.
authors.affiliation: Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Hidalgo
authors.forename: Arturo J
authors.initials: AJ
authors.lastname: Martí-Carvajal
authors.forename: Joey S W
authors.initials: JS
authors.lastname: Kwong
authors.forename: Daniel
authors.initials: D
authors.lastname: Simancas-Racines
authors.forename: Susana
authors.initials: S
authors.lastname: Nicola
mesh_terms: D000328:Adult; D002227:Carbazoles / Q000009:adverse effects / Q000627:therapeutic use*; D002316:Cardiotonic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000077261:Carvedilol; D002598:Chagas Cardiomyopathy / Q000150:complications*; D006333:Heart Failure / Q000188:drug therapy* / Q000209:etiology; D006801:Humans; D011412:Propanolamines / Q000009:adverse effects / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic
chemical_list: D002227:Carbazoles; D002316:Cardiotonic Agents; D011412:Propanolamines; D000077261:Carvedilol