Sacubitril/valsartan versus enalapril in chronic Chagas cardiomyopathy with heart failure: Baseline characteristics of the PARACHUTE-HF trial.

Abstract

AIMS The PARACHUTE-HF trial (NCT04023227) is evaluating the effect of sacubitril/valsartan compared with enalapril on a hierarchical composite of cardiovascular events (cardiovascular death, first heart failure hospitalization), and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels in participants with heart failure and reduced ejection fraction (HFrEF) caused by chronic Chagas cardiomyopathy (CCC). We describe the baseline characteristics of participants in PARACHUTE-HF compared with prior HFrEF trials. METHODS AND RESULTS PARACHUTE-HF, a multicentre, active-controlled, open-label trial, enrolled 922 participants with confirmed CCC, New York Heart Association (NYHA) functional class II-IV, and left ventricular ejection fraction (LVEF) ≤40%. Participants were randomized 1:1 to sacubitril/valsartan (97/103 mg bid) or enalapril (10 mg bid). Enrolled participants (mean age: 64.2 years, 42.0% women) had a baseline LVEF of 29.8% (NYHA class II: 61.7%; NHYA class III/IV: 38.2%). History included hypertension (40.5%), atrial fibrillation/flutter (32.5%), ventricular arrhythmia (24.7%) and stroke (12.5%). The majority of patients had cardiac conduction abnormalities and 46.0% had conventional pacemaker, cardiac resynchronization therapy or implantable cardioverter-defibrillator. Mean systolic blood pressure was 118 mmHg, and median NT-proBNP level was 1730 pg/ml. CONCLUSIONS Baseline characteristics of this study highlight the unique clinical profile of patients with CCC-related HFrEF, including the high proportion of women affected, lower rates of comorbidities (hypertension/diabetes) and higher prevalence of stroke and pacemaker implantation when compared with other non-CCC-related HFrEF studies. These findings reinforce the need for dedicated heart failure treatments in this neglected subpopulation, particularly in Latin America where Chagas disease remains a significant public health issue.