Novartis commences clinical programme to assess Entresto in heart failure

Novartis has announced a major new clinical programme to broaden understanding of the performance of its novel heart failure medicine Entresto.

The FortiHFy programme will be the largest global clinical programme in the area of heart failure disease to date, comprising more than 40 active or planned clinical studies. It is designed to generate an array of additional data on symptom reduction, efficacy, quality of life benefits and real-world evidence associated with Entresto.

Major trials will include PARAGON-HF, which examines the efficacy of Entresto in heart failure patients with preserved ejection fraction, as well as PARADISE-MI, which will test the hypothesis that Entresto can reduce cardiovascular death, hospitalisation rates and new onset heart failure in patients at high risk after a myocardial infarction.

Meanwhile, the TRANSITION study will compare in-hospital initiation of Entresto to initiation after hospital discharge in patients with reduced ejection fraction who have been hospitalised for acute decompensation.

Vas Narasimhan, global head of drug development and chief medical officer at Novartis, said: "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."