Sacubitril/Valsartan vs Enalapril in Heart Failure Due to Chagas Disease: An Open-Label, Multicenter Randomized Clinical Trial.
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Lopes Renato D, Bocchi Edimar Alcides, Echeverría Luis Eduardo, Demacq Caroline, de Barros E Silva Pedro Gabriel Melo, Barbosa Lilian Mazza, Damiani Lucas, Sayyed Sarfaraz, Yoshida Liandra A F, Furtado Remo Holanda M, Morillo Carlos A, Kevorkian Ruben, Ramires Felix, Bahit M Cecilia, Magaña Antonio, Chávez-Mendoza Adolfo, Miguel da Silva Adegil Henrique, Coelho da Silva Aguinaldo, Freitas Aguinaldo F, Romano Alfredo Alejandro, Parneix Anne, Segura Armando, França Cesar Cassio Broilo, Botta Cristian Edgardo, de Barros Edileide, Perna Eduardo Roque, Montenegro Eleonora, Quiroz Diaz Franklin Roberto, Feitosa-Filho Gilson Soares, Severini Graciela Viviana, Molina Israel, Miranda Jacqueline Dos Santos Sampaio, Sala Jorgelina, Kerr Saraiva José Francisco, Carbajales Justo, Maia Lilia Nigro, Santana Passos Luiz Carlos, Simões Marcus Vinicius, Moreira Maria da Consolação V, Nunes Maria Carmo P, Hernandes Mauro Esteves, Hominal Miguel, Zarandon Raquel Saa, Leon de la Fuente Ricardo, Aras Roque, Bazan Silméia Garcia Zanati, Luiz da Silva Telêmaco, Madrini Vagner, de Oliveira Wilson Alves, Saporito Wladmir Faustino, Gimpelewicz Claudio, McMurray John J V, Prevention and Reduction of Adverse Outcomes in Chagasic Heart Failure Trial Evaluation (PARACHUTE-HF) Investigators
Аннотация
OBJECTIVE: To evaluate the efficacy and safety of the angiotensin receptor-neprilysin inhibitor sacubitril/valsartan in patients with HF with reduced ejection fraction due to Chagas disease.
DESIGN, SETTING, AND PARTICIPANTS: From December 10, 2019, through September 13, 2023, patients with HF, confirmed diagnosis of Chagas disease, left ventricular ejection fraction of 40% or less, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) of 600 pg/mL or greater (or B-type natriuretic peptide [BNP] ≥150 pg/mL) or 400 pg/mL or greater (or BNP ≥100 pg/mL) if hospitalized for HF within the previous 12 months were screened at 83 sites in Argentina, Brazil, Colombia, and Mexico. Statistical analysis was conducted between May and July 2025.
INTERVENTIONS: Patients were randomized to receive sacubitril/valsartan (target dose, 200 mg twice daily) or enalapril (target dose, 10 mg twice daily), in addition to standard therapy.
MAIN OUTCOMES AND MEASURES: The primary end point was a hierarchical composite outcome tested, in order, of death from cardiovascular causes, hospitalization for HF, or relative change in NT-proBNP from baseline to 12 weeks. The primary analysis was done using a win ratio approach.
RESULTS: Overall, 462 participants were randomized to receive sacubitril/valsartan and 460 to receive enalapril (mean [SD] age, 64.2 [10.8] years; 387 [42.0%] were female). Over a median (IQR) follow-up of 25.2 (18.4-33.2) months, cardiovascular death occurred in 110 patients (23.8% [18.3% wins in the hierarchical comparison]) in the sacubitril/valsartan group and 117 patients (25.4% [17.5% wins]) in the enalapril group. A total of 102 patients (22.1% [7.7% wins]) in the sacubitril/valsartan group and 111 (24.1% [6.9% wins]) in the enalapril group experienced a first hospitalization for HF. Patients in the sacubitril/valsartan group had a median (IQR) decrease in NT-proBNP of 30.6% (-54.3% to -0.9%) at 12 weeks, leading to 22.5% wins, while those in the enalapril group had a 5.5% (-31.9% to 37.5%) decrease (7.2% wins). The resulting stratified win ratio was 1.52 (95% CI, 1.28-1.82; P < .001) for sacubitril/valsartan compared with enalapril.
CONCLUSIONS AND RELEVANCE: In patients with HF with reduced ejection fraction due to Chagas disease, there was no significant difference in clinical outcomes between sacubitril/valsartan and enalapril, but there was a greater reduction in NT-proBNP at 12 weeks in patients in the sacubitril/valsartan group.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04023227.