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 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.

Manejo de los pacientes con insuficiencia cardiaca atendidos en la consulta de cardiología: estudio IC-BERG / Management of patients with heart failure treated in cardiology consultations: IC-BERG Study

OBJETIVO: Conocer la percepción y el manejo del cardiólogo clínico de la insuficiencia cardiaca con fracción de eyección reducida (IC-FER) y establecer un consenso con recomendaciones. MÉTODOS: Se empleó el método Delphi modificado entre un panel de 150 expertos que respondieron un cuestionario que incluyó tres bloques: definición y percepción del paciente con IC-FER «estable» (15 afirmaciones), manejo del paciente con IC-FER «estable» (51 afirmaciones) y recomendaciones para optimizar el manejo y el seguimiento (9 afirmaciones). El nivel de acuerdo se evaluó utilizando una escala tipo Likert de 9 puntos. RESULTADOS: Se llegó a un consenso de acuerdo en 49 afirmaciones, a un consenso en el desacuerdo en 16 y quedaron indeterminadas 10 afirmaciones. Hubo consenso en cuanto a la definición de IC «estable» (82%), en que la IC-FER tiene una naturaleza silenciosa que puede contribuir a aumentar el riesgo de muerte en pacientes poco sintomáticos (96%), y que independientemente de que el paciente con IC-FER se mantenga estable en la misma clase funcional el tratamiento farmacológico debe optimizarse (98,7%). En cambio, hubo consenso en el desacuerdo con respecto a que el tratamiento con un inhibidor de neprilisina y receptor de angiotensina solo está justificado cuando hay un empeoramiento de la clase funcional (90,7%). CONCLUSIONES: El conocimiento actual sobre la IC «estable» es insuficiente; es necesaria la optimización del tratamiento, incluso en pacientes aparentemente estables, para disminuir el riesgo de progresión de la enfermedad

OBJECTIVE: To determine the perception and management of heart failure with reduced ejection fraction (HFrEF) by clinical cardiologists and to establish a consensus with recommendations. METHODS: We employed the modified Delphi method among a panel of 150 experts who answered a questionnaire that included three blocks: definition and perception of patients with «stable» HFrEF (15 statements), management of patients with «stable» HFrEF (51 statements) and recommendations for optimising the management and follow-up (9 statements). The level of agreement was assessed with a Likert 9-point scale. RESULTS: A consensus of agreement was reached on 49 statements, a consensus of disagreement was reached on 16, and 10 statements remained undetermined. There was consensus regarding the definition of «stable» HF (82%), that HFrEF had a silent nature that could increase the mortality risk for mildly symptomatic patients (96%) and that the drug treatment should be optimised, regardless of whether a patient with HFrEF remains stable in the same functional class (98.7%). In contrast, there was a consensus of disagreement regarding the notion that treatment with an angiotensin receptor-neprilysin inhibitor is justified only when the functional class worsens (90.7%). CONCLUSIONS: Our current understanding of «stable» HF is insufficient, and the treatment needs to be optimised, even for apparently stable patients, to decrease the risk of disease progression

Management of patients with heart failure treated in cardiology consultations: IC-BERG Study. / Manejo de los pacientes con insuficiencia cardiaca atendidos en la consulta de cardiología: Estudio IC-BERG.

OBJECTIVE: To determine the perception and management of heart failure with reduced ejection fraction (HFrEF) by clinical cardiologists and to establish a consensus with recommendations. METHODS: We employed the modified Delphi method among a panel of 150 experts who answered a questionnaire that included three blocks: definition and perception of patients with «stable¼ HFrEF (15 statements), management of patients with «stable¼ HFrEF (51 statements) and recommendations for optimising the management and follow-up (9 statements). The level of agreement was assessed with a Likert 9-point scale. RESULTS: A consensus of agreement was reached on 49 statements, a consensus of disagreement was reached on 16, and 10 statements remained undetermined. There was consensus regarding the definition of «stable¼ HF (82%), that HFrEF had a silent nature that could increase the mortality risk for mildly symptomatic patients (96%) and that the drug treatment should be optimised, regardless of whether a patient with HFrEF remains stable in the same functional class (98.7%). In contrast, there was a consensus of disagreement regarding the notion that treatment with an angiotensin receptor-neprilysin inhibitor is justified only when the functional class worsens (90.7%). CONCLUSIONS: Our current understanding of «stable¼ HF is insufficient, and the treatment needs to be optimised, even for apparently stable patients, to decrease the risk of disease progression.