Design and baseline characteristics of SALT-HF trial

Hypertonic saline solution (HSS) plus intravenous (IV) loop diuretic appears to enhance the diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this therapy in the ambulatory setting have not been evaluated. We aimed to describe the design and baseline chara...

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Detalhes bibliográficos
Autores: Cobo Marcos, M., Comín-Colet, Josep|||0000-0001-8780-720X, De la Espriella, Rafael|||0000-0002-8720-3999, Rubio Gracia, J., Morales-Rull, J.L., Zegrí-Reiriz, Isabel|||0000-0001-9742-8537, Llacer, P., Diez-Villanueva, P., Jiménez-Marrero, S., de Juan Bagudá, J., Ortiz Cortés, C., Goirigolzarri-Artaza, J., García-Pinilla, J.M., Barrios, E., del Prado Díaz, S., Montero Hernández, E., Sanchez-Marteles, M., Nuñez, J.
Formato: artículo
Fecha de publicación:2024
País:España
Recursos:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:305610
Acesso em linha:https://ddd.uab.cat/record/305610
https://dx.doi.org/urn:doi:10.1002/ehf2.14720
Access Level:acceso abierto
Palavra-chave:Diuretic resistance
Hypertonic saline solution
Hypertonic therapy
Outpatient with heart failure
Descrição
Resumo:Hypertonic saline solution (HSS) plus intravenous (IV) loop diuretic appears to enhance the diuretic response in patients hospitalized for heart failure (HF). The efficacy and safety of this therapy in the ambulatory setting have not been evaluated. We aimed to describe the design and baseline characteristics of the SALT-HF trial participants. 'Efficacy of Saline Hypertonic Therapy in Ambulatory Patients with HF' (SALT-HF) trial was a multicenter, double-blinded, and randomized study involving ambulatory patients who experienced worsening heart failure (WHF) without criteria for hospitalization. Enrolled patients had to present at least two signs of volume overload, use ≥ 80 mg of oral furosemide daily, and have elevated natriuretic peptides. Patients were randomized 1:1 to treatment with a 1-h infusion of IV furosemide plus HSS (2.6-3.4% NaCl depending on plasmatic sodium levels) versus a 1-h infusion of IV furosemide at the same dose (125-250 mg, depending on basal loop diuretic dose). Clinical, laboratory, and imaging parameters were collected at baseline and after 7 days, and a telephone visit was planned after 30 days. The primary endpoint was 3-h diuresis after treatment started. Secondary endpoints included (a) 7-day changes in congestion data, (b) 7-day changes in kidney function and electrolytes, (c) 30-day clinical events (need of IV diuretic, HF hospitalization, cardiovascular mortality, all-cause mortality or HF-hospitalization). A total of 167 participants [median age, 81 years; interquartile range (IQR), 73-87, 30.5% females] were randomized across 13 sites between December 2020 and March 2023. Half of the participants (n = 82) had an ejection fraction.