Domenico Acanfora1, Pietro Scicchitano2, Chiara Acanfora1, Roberto Maestri3, Fernando Goglia4, Raffaele Antonelli Incalzi5, Alessandro Santo Bortone6, Marco Matteo Ciccone7, Massimo Uguccioni8, Gerardo Casucci1. 1. Department of Internal Medicine, San Francesco Hospital, Viale Europa 21, 82037, Telese Terme, BN, Italy. 2. Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare, 11, 70124, Bari, Italy. piero.sc@hotmail.it. 3. Maugeri Scientific Clinical Institutes, SpA SB, Institute of Care and Scientific Research, Rehabilitation Institute of Montescano, Pavia, Italy. 4. Maugeri Scientific Clinical Institutes, SpA SB, Institute of Care and Scientific Research, Rehabilitation Institute of Telese Terme, Telese Terme, BN, Italy. 5. Unit of Geriatrics, Policlinico Universitario, Campus Bio-Medico di Roma, Via Álvaro del Portillo 21, 00128, Rome, Italy. 6. Division of Cardiac Surgery, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. 7. Section of Cardiovascular Diseases, Department of Emergency and Organ Transplantation, School of Medicine, University of Bari, Piazza G. Cesare, 11, 70124, Bari, Italy. 8. Cardiology Unit, San Camillo Hospital, Rome, Italy.
Abstract
BACKGROUND AND OBJECTIVE: Sacubitril/valsartan improved the prognosis of patients with heart failure with reduced ejection fraction in the PARADIGM-HF study. Recently, the TRANSITION and PIONEER-HF studies demonstrated the safety and efficacy of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure, with treatment initiated after hemodynamic and clinical stabilization. In this case series study, we assessed the short-term effects of sacubitril/valsartan on exercise capacity, inflammation, and biomarkers in patients with acute decompensated heart failure. METHODS: Patients admitted for acute decompensated heart failure to the Department of Internal Medicine of Telese Terme Hospital and Cardiovascular Department, University of Bari, from 9 March, 2017 to 9 June, 2018 were enrolled. Following hemodynamic stabilization, patients initiated sacubitril/valsartan 24/26 mg twice a day for 4 weeks, with up-titration to 49/51 mg twice a day based on tolerability after 1 week. Efficacy outcomes included the 6-min walking test, N-terminal pro-B-type natriuretic peptide, high-sensitivity C-reactive protein, and lymphocyte count. Safety outcomes included renal function, hyperkalemia, and symptomatic hypotension. RESULTS: In total, 40 patients completed the study and 27 (67.5%) patients were up-titrated. Compared with baseline, exercise capacity and relative lymphocyte count increased significantly after 4 weeks of treatment, while N-terminal pro-B-type natriuretic peptide and high-sensitivity C-reactive protein decreased significantly. N-terminal pro-B-type natriuretic peptide and relative lymphocyte count independently predicted the 6-min walking test distance (p = 0.021). No patients experienced any relevant side effects. CONCLUSIONS: Early initiation of sacubitril/valsartan in patients with heart failure with reduced ejection fraction after acute decompensated heart failure may be safe and effective in terms of functional capacity and biomarkers.
BACKGROUND AND OBJECTIVE:Sacubitril/valsartan improved the prognosis of patients with heart failure with reduced ejection fraction in the PARADIGM-HF study. Recently, the TRANSITION and PIONEER-HF studies demonstrated the safety and efficacy of sacubitril/valsartan in patients hospitalized for acute decompensated heart failure, with treatment initiated after hemodynamic and clinical stabilization. In this case series study, we assessed the short-term effects of sacubitril/valsartan on exercise capacity, inflammation, and biomarkers in patients with acute decompensated heart failure. METHODS:Patients admitted for acute decompensated heart failure to the Department of Internal Medicine of Telese Terme Hospital and Cardiovascular Department, University of Bari, from 9 March, 2017 to 9 June, 2018 were enrolled. Following hemodynamic stabilization, patients initiated sacubitril/valsartan 24/26 mg twice a day for 4 weeks, with up-titration to 49/51 mg twice a day based on tolerability after 1 week. Efficacy outcomes included the 6-min walking test, N-terminal pro-B-type natriuretic peptide, high-sensitivity C-reactive protein, and lymphocyte count. Safety outcomes included renal function, hyperkalemia, and symptomatic hypotension. RESULTS: In total, 40 patients completed the study and 27 (67.5%) patients were up-titrated. Compared with baseline, exercise capacity and relative lymphocyte count increased significantly after 4 weeks of treatment, while N-terminal pro-B-type natriuretic peptide and high-sensitivity C-reactive protein decreased significantly. N-terminal pro-B-type natriuretic peptide and relative lymphocyte count independently predicted the 6-min walking test distance (p = 0.021). No patients experienced any relevant side effects. CONCLUSIONS: Early initiation of sacubitril/valsartan in patients with heart failure with reduced ejection fraction after acute decompensated heart failure may be safe and effective in terms of functional capacity and biomarkers.
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