Key result
Sacubitril/valsartan linked to ~12% higher LVEF and lower mortality vs standard therapy in HFrEF.
Why the study?
HFrEF remains a prevalent syndrome with high morbidity and mortality, prompting evaluation of the clinical efficacy and effects on hemodynamic, metabolic, renal, and remodeling parameters of sacubitril/valsartan in ambulatory patients.
Does sacubitril/valsartan improve hemodynamic, renal, and clinical outcomes in ambulatory patients with HFrEF compared to standard optimal medical therapy?
Cohort (n=106)
Open-label
No
Does sacubitril/valsartan improve hemodynamic, renal, and clinical outcomes in ambulatory patients with HFrEF compared to standard optimal medical therapy?
Absolute Event Rate: 42.1% vs 30.1%
p-value: p=<0.001
In ambulatory patients with HFrEF, switching to sacubitril/valsartan significantly improves cardiac remodeling, renal function, and clinical outcomes including mortality and HF hospitalizations compared to standard optimal medical therapy.
May support ARNI use in ambulatory HFrEF; leaves open confirmation by randomized trials.
Background: The prevalence of chronic heart failure (CHF) is up to 1-2% of the adult population in developed countries, rising to >10% after the age of 70. Heart failure with reduced ejection fraction (HFrEF) remains a prevalent clinical syndrome associated with significant morbidity and mortality. Objective: The aim of this study was to evaluate the clinical efficacy of sacubitril/valsartan in a group of ambulatory patients with heart failure with reduced ejection fraction (HFrEF) and its effect on the hemodynamic, metabolic, renal, and cardiac remodeling parameters. Methods: From January 2018 to May 2021, 106 patients with chronic heart failure with reduced ejection fraction (HFrEF) were prospectively enrolled. Patients treated with sacubitril/valsartan (ARNI) were compared with an arm of the same size (n = 53) and matched by age and gender who were taking a standard optimal medical therapy for HFrEF. Results: The 106 patients completing the study were characterized by age: 69.5 ± 8.0, 64% are male gender. The mean duration of follow-up in the 2 treatment arms was 12 months. In the ARNI arm, we evaluate the hemodynamic, metabolic, renal, and cardiac remodeling parameters upon the initial evaluation and at the end of the follow-up after 12 months treatment with sacubitril/valsartan. The LVEF values increased significantly (p < 0.001) in the ARNI arm compared to the OMT arm, 42.1 % vs. 30.1%. The LVMI decreased from a baseline value of 153.1 g/m2 to 147.8 g/m2 with significant improvement only in the arm treated with ARNI. The eGFR values increased significantly (p < 0.001) in the ARNI arm compared to the OMT arm 70.1 vs. 64.9 mL/min/1.73 m2. Initiation and titration of sacubitril-valsartan was associated with a reduction in NT-pro-BNP concentration, the values of NT-pro-BNP improved significantly only in the arm treated with ARNI 3107.1 vs. 5678.2. Mortality and re-hospitalization due to HF were lower in the arm treated with ARNI compared to the control (20.3 vs. 32.4 % and 25.3 vs. 46.6 %, respectively; p < 0.05). Conclusion: Sacubitril/valsartan is an important advancement in the treatment of HFrEF. Sacubitril/valsartan induce "hemodynamic recovery". This study provides real-world data demonstrating incremental improvements in functional and echocardiographic outcomes in optimally treated patients with HFrEF switched to sacubitril/valsartan in ambulatory setting.
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Naser et al. (2022) conducted a cohort in Chronic heart failure with reduced ejection fraction (HFrEF) (n=106). Sacubitril/Valsartan vs. Standard optimal medical therapy (ACEI or ARB, beta-blocker, and MRA) was evaluated on Left ventricular ejection fraction (LVEF) at 12 months (p=<0.001). Sacubitril/valsartan significantly improved left ventricular ejection fraction to 42.1% compared to 30.1% with standard therapy and reduced mortality and re-hospitalization in patients with HFrEF.
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