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Pharmacological interventions for treating heart failure in patients with chagas cardiomyopathy
Ricardo Hidalgo1, Arturo J Martí-Carvajal, Joey S W Kwong
1Facultad de Ciencias de la Salud Eugenio Espejo, Universidad Tecnológica Equinoccial, Quito, Ecuador.
Insights
Limited evidence exists for carvedilol in treating Chagas disease cardiomyopathy. Two small, high-risk trials found no significant effect on mortality, highlighting the need for further research on heart failure treatments.
Area of Science:
- Cardiology
- Infectious Diseases
- Pharmacology
Background:
- Chagas disease-related cardiomyopathy (CCC) is a significant cause of illness and death in Latin America.
- Current pharmacological treatments for heart failure in CCC patients lack proven efficacy and safety data.
Purpose of the Study:
- To evaluate the benefits and harms of pharmacological interventions for heart failure in patients with Chagas cardiomyopathy.
Main Methods:
- A systematic search of multiple databases (Cochrane CENTRAL, MEDLINE, EMBASE, LILACS, Web of Science) was conducted up to April 2011.
- Included were randomized clinical trials of adult patients with symptomatic heart failure (NYHA class II-IV) and CCC.
- Primary outcomes included all-cause mortality, cardiovascular mortality, heart decompensation, disease-free period, and adverse events.
Main Results:
- Two randomized clinical trials with 69 participants were included, both comparing carvedilol to placebo and exhibiting high risk of bias.
- Carvedilol did not significantly impact all-cause mortality compared to placebo (RR 0.69, 95% CI 0.12-3.88).
- Data on cardiovascular mortality, heart decompensation, disease-free periods, and adverse events were insufficient or inconclusive.
Conclusions:
- There is a substantial lack of evidence regarding the efficacy and safety of carvedilol for treating heart failure in Chagas cardiomyopathy.
- The included trials were underpowered and had a high risk of bias, precluding definitive conclusions.
- Caution is advised for policymakers, clinicians, and researchers regarding carvedilol use in CCC until robust evidence from randomized clinical trials is available.
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.
Objectives:
To assess the benefits and harms of current pharmacological interventions for treating heart failure in patients with Chagas cardiomyopathy.
Search 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.
Selection Criteria:
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.
Data Collection And Analysis:
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.
Main 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.
Authors' 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.
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