Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure
Aims: 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...
| Autores: | , , , , , , , , , , , , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2024 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:10459.1/465747 |
| Acceso en línea: | https://doi.org/10.1002/ehf2.14720 https://hdl.handle.net/10459.1/465747 |
| Access Level: | acceso abierto |
| Palabra clave: | Diuretic resistance Hypertonic saline solution Hypertonic therapy Outpatient with heart failure |
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Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failureCobo Marcos, M.Comín Colet, Josepde la Espriella , RafaelRubio Gracia, J.Morales Rull, José LuisZegrí, I.Llàcer, PauDíez-Villanueva, PabloJiménez-Marrero, S.de Juan Bagudá, J.Ortiz Cortés, C.Goirigolzarri-Artaza, J.García Pinilla, José ManuelBarrios, E.del Prado Díaz, S.Montero Hernández, E.Sanchez-Marteles, M.Núñez, JulioDiuretic resistanceHypertonic saline solutionHypertonic therapyOutpatient with heart failureAims: 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. Methods and results: '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). Results: 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 >50%. Most patients showed a high burden of comorbidities, with a median Charlson index of 3 (IQR: 2-4). Common co-morbidities included diabetes mellitus (41%, n = 69), atrial fibrillation (80%, n = 134), and chronic kidney disease (64%, n = 107). Patients exhibited a poor functional NYHA class (69% presenting NYHA III) and several signs of congestion. The mean composite congestion score was 4.3 (standard deviation: 1.7). Ninety per cent of the patients (n = 151) presented oedema and jugular engorgement, and 71% (n = 118) showed lung B lines assessed by ultrasound. Median inferior vena cava diameter was 23 mm, (IQR: 21-25), and plasmatic levels of N-terminal-pro-B-type natriuretic peptide (NTproBNP) and antigen carbohydrate 125 (CA125) were increased (median NT-proBNP 4969 pg/mL, IQR: 2508-9328; median CA125 46 U/L, IQR: 20-114). Conclusions: SALT-HF trial randomized 167 ambulatory patients with WHF and will determine whether an infusion of hypertonic saline therapy plus furosemide increases diuresis and improves decongestion compared to equivalent furosemide administration alone.Wiley2024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionhttps://doi.org/10.1002/ehf2.14720https://hdl.handle.net/10459.1/465747reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésReproducció del document publicat a: https://doi.org/10.1002/ehf2.14720ESC Heart Failure, 2024 [Online ahead of print]cc-by-nc-nd (c) Authors, 2024Attribution-NonCommercial-NoDerivatives 4.0 Internationalinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by-nc-nd/4.0/oai:recercat.cat:10459.1/4657472026-05-29T05:05:01Z |
| dc.title.none.fl_str_mv |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| title |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| spellingShingle |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure Cobo Marcos, M. Diuretic resistance Hypertonic saline solution Hypertonic therapy Outpatient with heart failure |
| title_short |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| title_full |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| title_fullStr |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| title_full_unstemmed |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| title_sort |
Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure |
| dc.creator.none.fl_str_mv |
Cobo Marcos, M. Comín Colet, Josep de la Espriella , Rafael Rubio Gracia, J. Morales Rull, José Luis Zegrí, I. Llàcer, Pau Díez-Villanueva, Pablo Jiménez-Marrero, S. de Juan Bagudá, J. Ortiz Cortés, C. Goirigolzarri-Artaza, J. García Pinilla, José Manuel Barrios, E. del Prado Díaz, S. Montero Hernández, E. Sanchez-Marteles, M. Núñez, Julio |
| author |
Cobo Marcos, M. |
| author_facet |
Cobo Marcos, M. Comín Colet, Josep de la Espriella , Rafael Rubio Gracia, J. Morales Rull, José Luis Zegrí, I. Llàcer, Pau Díez-Villanueva, Pablo Jiménez-Marrero, S. de Juan Bagudá, J. Ortiz Cortés, C. Goirigolzarri-Artaza, J. García Pinilla, José Manuel Barrios, E. del Prado Díaz, S. Montero Hernández, E. Sanchez-Marteles, M. Núñez, Julio |
| author_role |
author |
| author2 |
Comín Colet, Josep de la Espriella , Rafael Rubio Gracia, J. Morales Rull, José Luis Zegrí, I. Llàcer, Pau Díez-Villanueva, Pablo Jiménez-Marrero, S. de Juan Bagudá, J. Ortiz Cortés, C. Goirigolzarri-Artaza, J. García Pinilla, José Manuel Barrios, E. del Prado Díaz, S. Montero Hernández, E. Sanchez-Marteles, M. Núñez, Julio |
| author2_role |
author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
Diuretic resistance Hypertonic saline solution Hypertonic therapy Outpatient with heart failure |
| topic |
Diuretic resistance Hypertonic saline solution Hypertonic therapy Outpatient with heart failure |
| description |
Aims: 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. Methods and results: '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). Results: 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 >50%. Most patients showed a high burden of comorbidities, with a median Charlson index of 3 (IQR: 2-4). Common co-morbidities included diabetes mellitus (41%, n = 69), atrial fibrillation (80%, n = 134), and chronic kidney disease (64%, n = 107). Patients exhibited a poor functional NYHA class (69% presenting NYHA III) and several signs of congestion. The mean composite congestion score was 4.3 (standard deviation: 1.7). Ninety per cent of the patients (n = 151) presented oedema and jugular engorgement, and 71% (n = 118) showed lung B lines assessed by ultrasound. Median inferior vena cava diameter was 23 mm, (IQR: 21-25), and plasmatic levels of N-terminal-pro-B-type natriuretic peptide (NTproBNP) and antigen carbohydrate 125 (CA125) were increased (median NT-proBNP 4969 pg/mL, IQR: 2508-9328; median CA125 46 U/L, IQR: 20-114). Conclusions: SALT-HF trial randomized 167 ambulatory patients with WHF and will determine whether an infusion of hypertonic saline therapy plus furosemide increases diuresis and improves decongestion compared to equivalent furosemide administration alone. |
| publishDate |
2024 |
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2024 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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https://doi.org/10.1002/ehf2.14720 https://hdl.handle.net/10459.1/465747 |
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https://doi.org/10.1002/ehf2.14720 https://hdl.handle.net/10459.1/465747 |
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Inglés |
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Inglés |
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Reproducció del document publicat a: https://doi.org/10.1002/ehf2.14720 ESC Heart Failure, 2024 [Online ahead of print] |
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cc-by-nc-nd (c) Authors, 2024 Attribution-NonCommercial-NoDerivatives 4.0 International info:eu-repo/semantics/openAccess http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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cc-by-nc-nd (c) Authors, 2024 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ |
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openAccess |
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Wiley |
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Wiley |
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reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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Recercat. Dipósit de la Recerca de Catalunya |
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