Design and baseline characteristics of SALT-HF trial: hypertonic saline therapy in ambulatory heart failure
Por:
Marcos, MC, Comin-Colet, J, de la Espriella, R, Gracia, JR, Morales-Rull, JL, Zegri, I, Llacer, P, Diez-Villanueva, P, Jimenez-Marrero, S, Bagudá, JD, Cortés, CO, Goirigolzarri-Artaza, J, Garcia-Pinilla, JM, Barrios, E, Díaz, SD, Hernández, EM, Sanchez-Marteles, M, Nuñez, J
Publicada:
21 feb 2024
Ahead of Print:
1 feb 2024
Resumen:
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.
Filiaciones:
Marcos, MC:
Hosp Univ Puerta de Hierro, Dept Cardiol, Madrid, Spain
Ctr Invest Biomed Red CIBER Cardiovasc, Madrid, Spain
Comin-Colet, J:
Ctr Invest Biomed Red CIBER Cardiovasc, Madrid, Spain
Hosp Univ Bellvitge, Dept Cardiol, IDIBELL, Barcelona, Spain
de la Espriella, R:
Univ Valencia, Hosp Clin Univ Valencia INCL, Dept Cardiol, Valencia, Spain
Gracia, JR:
Univ Zaragoza, Hosp Univ Lozano Blesa, Aragon Hlth Res Inst IIS Aragon, Dept Internal Med, Zaragoza, Spain
Morales-Rull, JL:
Hosp Arnau Vilanova, Dept Internal Med, Lleida, Spain
Inst Recerca Biomed Lleida IRBLleida, Heart Failure Unit, Lleida Hlth Reg, Lleida, Spain
Zegri, I:
Hosp Santa Creu & Sant Pau, Dept Cardiol, Barcelona, Spain
Llacer, P:
Hosp Univ Ramon y Cajal, Dept Internal Med, IRYCIS, Madrid, Spain
Univ Alcala, Fac Med & Ciencias Salud, Dept Med & Med Specialties, Madrid, Spain
Diez-Villanueva, P:
Hosp Univ Princesa, Dept Cardiol, Madrid, Spain
Jimenez-Marrero, S:
Hosp Univ Bellvitge, Dept Cardiol, IDIBELL, Barcelona, Spain
Bagudá, JD:
Ctr Invest Biomed Red CIBER Cardiovasc, Madrid, Spain
Univ Hosp 12 Octubre, Inst Invest Sanitaria Hosp Octubre 12 imas12, Dept Cardiol, Madrid, Spain
Inst Salud Carlos III, Madrid, Spain
Univ Europea Madrid, Fac Biomed & Hlth Sci, Dept Med, Madrid, Spain
Cortés, CO:
Hosp Univ San Pedro Alcantara, Dept Cardiol, Caceres, Spain
Goirigolzarri-Artaza, J:
Hosp Univ Clin San Carlos, Dept Cardiol, Madrid, Spain
Garcia-Pinilla, JM:
Hosp Univ Virgen de la Victoria, Dept Cardiol, Malaga, Spain
Inst Invest Biomed Plataforma BIONAND Malaga Ciber, Malaga, Spain
Univ Malaga, Dept Med & Dermatol, Insitituto Salud Carlos III, Malaga, Spain
Barrios, E:
Hosp Univ Rey Juan Carlos Mostoles, Dept Cardiol, Madrid, Spain
Díaz, SD:
Ctr Invest Biomed Red CIBER Cardiovasc, Madrid, Spain
Hosp Univ Ramon & Cajal, Dept Cardiol, Madrid, Spain
Hernández, EM:
Hosp Univ Puerta Hierro Majadahonda, Dept Internal Med, Madrid, Spain
Sanchez-Marteles, M:
Univ Zaragoza, Hosp Univ Lozano Blesa, Aragon Hlth Res Inst IIS Aragon, Dept Internal Med, Zaragoza, Spain
Nuñez, J:
Ctr Invest Biomed Red CIBER Cardiovasc, Madrid, Spain
Univ Valencia, Hosp Clin Univ Valencia INCL, Dept Cardiol, Valencia, Spain
Hosp Clin Univ Valencia, Univ Valencia, Dept Cardiol, Dept Med, Avda Blasco Ibanez 17, Valencia 46010, Spain
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