Novartis establishes new global clinical programme of Entresto and heart failure

22 May 2016 (Last Updated May 22nd, 2016 18:30)

Swiss pharmaceutical company Novartis has established a global clinical programme, Fortifying Heart Failure clinical evidence and patient quality of life (FortiHFy), to address the heart failure disease area across the pharmaceutical industry.

Swiss pharmaceutical company Novartis has established a global clinical programme, Fortifying Heart Failure clinical evidence and patient quality of life (FortiHFy), to address the heart failure disease area across the pharmaceutical industry.

The programme involves more than 40 active or planned clinical studies designed to create an array of additional data on efficacy, symptom reduction and quality of life benefits, as well as precise evidence with its heart failure medicine Entresto (sacubitril / valsartan).

Novartis drug development global head and chief medical officer Dr Vas Narasimhan said: "The FortiHFy programme 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."

"The FortiHFy programme reinforces our long-term commitment to improving heart failure treatment for as many people as possible."

Entresto needs to be taken twice daily and helps reduce the stress on a failing heart by increasing the protective neurohormonal systems of the heart (NP system), while simultaneously reducing the harmful effects of the overactive renin-angiotensin-aldosterone system (RAAS).

The primary trials under the FortiHFy programme include Paragon-HF, Parardise-MI, Transition, and Pioneer.

Paragon-HF will study the efficacy, as well as safety of Entresto in heart failure patients with preserved ejection fraction.

Parardise-MI will test the hypothesis that Entresto has the potentiality to reduce instances of heart failure hospitalisations, cardiovascular death and new onset heart failure in patients at high risk for heart failure after a myocardial infarction.

The transition trial will help compare in-hospital initiation of Entresto with initiation after hospital discharge in heart failure patients with reduced ejection fraction (HFrEF) who have recently been hospitalised for severe decompensation.

Pioneer will examine the effect of in-hospital initiation of Entresto on changes in NT-proBNP, compared to enalapril in patients suffering from HFrEF after a severe decompensation.

Entresto is currently approved in 57 countries across the globe to be used for the treatment of heart failure with reduced ejection fraction (HFrEF).