Abstract Body (Do not enter title and authors here): Background:
Chronic Chagas cardiomyopathy (CCC) represents a common cause of non-ischemic heart failure with reduced ejection fraction (HFrEF) in Latin America, yet evidence from randomized controlled trials to guide the management of these patients remains scarce. Sacubitril-valsartan has shown benefits in HFrEF of other etiologies, but less in known about its effects on CCC.
Methods:
ANSWER-HF was a randomized, double-blind, controlled trial, conducted in Brazil. A total of 190 patients with CCC and HFrEF (left ventricular ejection fraction [LVEF] <40%, New York Heart Association class II–IV) were randomized in a 1:1 ratio to sacubitril-valsartan or enalapril and followed for 6 months. The primary endpoint was the change in LVEF from baseline to 6 months. The win ratio method was used for the analysis of the hierarchical key secondary endpoint of cardiovascular death, heart failure hospitalization, NT-proBNP change, and LVEF change.
Results:
Mean age was 61 years, 40% were women, and 69% self-identified as Black or Mixed Race . Baseline mean LVEF was 30.1%. At 6 months, mean LVEF increased by 2.1% with sacubitril-valsartan and 1.2% with enalapril (between-group difference 0.8 percentage points; 95% CI, –0.9 to 2.6; P=0.36). In the hierarchical analysis, sacubitril-valsartan achieved more total wins than enalapril (win ratio 1.80; 95% CI, 1.27–2.63). Median NT-proBNP was significantly lower with sacubitril-valsartan compared with enalapril (geometric mean ratio 0.68; 95% CI, 0.57–0.81; P<0.001). No significant differences were observed in echocardiographic remodeling or 6-minute walk distance between study groups and the occurrence of safety outcomes were comparable.
Conclusions:
In patients with CCC and HFrEF, sacubitril-valsartan did not result in significant improvements in LVEF compared with enalapril after 6 months, but was associated with a greater reduction in NT-proBNP. There were no safety concerns associated with either sacubitril-valsartan or enalapril in this population. These findings provide high quality evidence about the efficacy and safety of sacubitril-valsartan and enalapril in HFrEF due to CCC and may help physicians in the decision-making process when treating this high-risk group of patients. (Sacubitril-Valsartan Versus Enalapril in Heart Failure Due to Chagas Disease: The Primary Results of the ANSWER-HF Randomized Trial: NCT04853758.)