Novartis announces FortiHFy clinical trial programme for Entresto (sacubitril/valsartan) for heart failure.

Novartis has announced the establishment of FortiHFy, the largest global clinical program in the heart failure disease area across the pharma industry to date, comprising over 40 active or planned clinical studies designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real world evidence with its novel heart failure medicine Entresto (sacubitril/valsartan), and extend understanding of heart failure.

Major trials in the FortiHFy program include: • PARAGON-HF examining the efficacy and safety of Entresto in heart failure patients with with preserved ejection fraction (compared to valsartan), expected study completion in 2019. • PARADISE-MI testing the hypothesis that Entresto can reduce cardiovascular death, heart failure hospitalizations and new onset heart failure in patients at high risk for heart failure after a myocardial infarction, expected study completion in 2020. • TRANSITION comparing in-hospital initiation of Entresto to initiation after hospital discharge in heart failure patients with reduced ejection fraction (HFrEF) who have recently been hospitalized for acute decompensation, expected study completion in 2018. • PIONEER investigating the effect of in-hospital initiation of Entresto on changes in NT-proBNP (compared to enalapril) in patients with HFrEF following an acute decompensation, expected study completion in 2018.

FortiHFy trials that are already active are posted on clinicaltrials.gov and are currently enrolling patients in more than 50 countries worldwide. Entresto is approved in 57 countries to date for the treatment of heart failure with reduced ejection fraction (HFrEF), based on data from the PARADIGM-HF study which reported results in 2014.