The studies have been designed to give an array of additional data on reduction in symptoms, efficacy, quality of life benefits, to improve understanding about heart failure and to test the real world evidence for Novartis’ heart failure medicine Entresto (sacubitril/valsartan).
According to Novartis, major trials in the FortiHFy program include the PARAGON-HF, which examines the efficacy and safety of Entresto in patients with heart failure with preserved injection fraction (compared to valsartan). The study is expected to be completed by 2019.
Trial under PARADISE-MI will test the hypothesis whether Entresto can reduce cardiovascular death, heart failure hospitalisations and new onset of heart failure in patients with high risk for heart failure after myocardial infarction. The study is expected to be completed in 2020.
TRANSITION trial will compare administration of Entresto in hospitals and its administration after discharge from hospital in heart failure patients with reduced ejection fraction (HFrEF) who were hospitalised recently following acute decompensation. The study is expected to complete in 2018.
Under PIONEER trial, the company will investigate the effect of Entresto administration in hospital on changes in NT-proBNP (compared to enalpril) in patients with HFrEF following an acute decompensation. The study will be completed in 2018.
Novartis, global head, drug development and chief medical officer Vas Narasimhan said: "The FortiHFy program reinforces our long term commitment to improving heart failure treatment for as many people as possible.
"The outcomes of these trials will increase our understanding of heart failure, the patient population who may benefit from Entresto, and could potentially support applications to regulatory authorities."
Novartis says that trials of FortiHFy are already being submitted on clinicaltrials.gov and the program is currently enrolling patients in more than 50 countries worldwide.