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Sacubitril/Valsartan in Real-Life Practice: Experience in Patients with Advanced Heart Failure and Systematic Review
Carles Moliner-Abós1, Mercedes Rivas-Lasarte1, Julia Pamies Besora1
1Cardiology Department, Hospital de la Santa Creu i Sant Pau, IIB-SantPau, CIBERCV, Universidad Autónoma de Barcelona, Calle Sant Antoni Maria Claret 167, 08025, Barcelona, Spain.
Insights
Sacubitril/valsartan effectively reduced heart failure hospitalizations and improved cardiac function in advanced heart failure patients in real-world practice. The medication demonstrated a good safety profile, with no severe adverse events observed during the follow-up period.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Sacubitril/valsartan demonstrated efficacy in the PARADIGM-HF trial for heart failure (HF) admissions and cardiovascular mortality.
- Real-world data comparing daily practice patients with trial participants are limited.
Purpose of the Study:
- To analyze the efficacy and safety of sacubitril/valsartan in an advanced heart failure cohort.
- To systematically review previous real-life studies on sacubitril/valsartan.
Main Methods:
- Retrospective analysis of 108 patients prescribed sacubitril/valsartan in a tertiary HF clinic (Sept 2016 - Feb 2018).
- Assessed HF admissions before and after drug initiation.
- Conducted a systematic review of published real-life studies.
Main Results:
- Patients were in a more advanced NYHA class than in PARADIGM-HF.
- Observed significant reduction in HF hospitalizations, NT-proBNP levels, and need for levosimendan.
- Found significant improvement in LVEF and left ventricle diameter.
- Sacubitril/valsartan was well-tolerated with no severe adverse effects.
Conclusions:
- Sacubitril/valsartan is prescribed to advanced HF populations in real-world settings.
- Despite challenges in achieving high doses, the drug significantly reduces HF hospitalizations and improves cardiac reverse remodeling.
- Demonstrated a favorable safety profile in this advanced HF cohort.
Purpose:
Sacubitril/valsartan reduced heart failure (HF) admissions and cardiovascular mortality in the PARADIGM-HF trial. However, real-life studies are scarce comparing daily practice patients with those of the trial. The aim of our study was to analyze the efficacy and safety of the drug in an advanced heart failure cohort and to review systematically the previous real-life studies published to date.
Methods:
We performed a retrospective analysis of consecutive patients prescribed sacubitril/valsartan in a single tertiary HF clinic between September 2016 and February 2018. HF admissions before and after the initiation of the drug were assessed in a paired fashion. A systematic review of real-life studies published to date was also conducted.
Results:
Sacubitril/valsartan was started in 108 patients who were in a more advanced NYHA class and more frequently treated with mineral receptor antagonists, internal cardiac defibrillator, and cardiac resynchronization therapy than in the PARADIGM-HF trial. After a 6-month follow-up, we observed a significant reduction in the HF hospitalizations, median levels of NT-proBNP, and need for levosimendan ambulatory perfusion. Likewise, we found a significant improvement in mean LVEF and end diastolic left ventricle diameter. Regarding safety, sacubitril/valsartan was well-tolerated without any severe adverse effect.
Conclusion:
Sacubitril/valsartan in real-life is prescribed to a more advanced HF population, which could be responsible for the difficulties in reaching high doses of the drug. However, after a 6-month follow-up, sacubitril/valsartan significantly reduces HF hospitalization and induces cardiac reverse remodeling, without remarkable adverse events.
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