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European journal of heart failure · 2025

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

СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеНазвание и аннотация: Перевод в очереди
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Echeverria Luis Eduardo, Bocchi Edimar, Demacq Caroline, de Barros E Silva Pedro Gabriel Melo, Chiang Lu-May, Sayyed Sarfaraz, Damiani Lucas Petri, Barbosa Lilian Mazza, Furtado Remo Holanda de Mendonça, Morillo Carlos A, Kevorkian Ruben, Ramires Felix, Bahit Maria Cecilia, Chavez-Mendoza Adolfo, Magaña-Serrano José Antonio, Carbajales Justo, Oliveira Junior Wilson, Molina Israel, Freitas Junior Aguinaldo F, Moreira Maria da Consolaçao, Silva Adegil Henrique, Silva Junior Telemaco, Saporito Wladimir, Kerr Saraiva José Francisco, Gimpelewicz Claudio, McMurray John J V, Lopes Renato Delascio, on behalf of the PARACHUTE‐HF Investigators

Аннотация

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.

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