BIOTOOL-CHF · BIOmarker based diagnostic TOOLkit to personalize pharmacological approaches in congestive heart failure

Heart failure (HF) is a chronic clinical condition involving up to 6.5 million people in Europe, the most frequent cause of hospitalization in adults with a 5-year mortality rate up to 70%. Several drugs positively modify the course of disease in the patients with HF with reduced ejection fraction (HFrEF), with a high level of evidence. Besides, the use of diuretics, the basic cornerstone of symptoms relief in HFrEF by targeting congestion, is supported by poor and outdated evidence. Congestion drives symptoms worsening leading to hospital admission. Clinical evaluation of congestion is often inaccurate and insensitive to detect interstitial or intravascular fluid overload, and thus insufficient to guide use of diuretics. Indeed, their use is inefficient, with studies showing that up to 70% of patients with chronic HFrEF show congestion despite diuretic therapy, the use of diuretics does prevent clinical events in patients discharged after an acute heart failure episode, and diuretics may represent a barrier to adherence to disease modifier therapies. An appropriate management of diuretic therapy is therefore crucial to overcome the risk of re-hospitalisation, manage patients symptoms, and achieve target guideline-directed medical therapy. To fill these gaps, BIOTOOL-CHF will 1) validate a set of qualified biomarkers estimating congestion, 2) define a multiparametric artificial intelligence-based score predicting congestion and prognosis, 3) develop a decision-making tool to manage congestion by diuretics, 4) develop a Point of Care companion diagnostic (CD) to assess biomarkers concentrations 5) set up a Strategy plan for industrial development and market access of the CD. This approach will support the definition of a framework to regulatory agencies and scientific societies to disseminate recommendations for a more efficient use of existing pharmaceuticals and allow a personalised strategy for the management of HFrEF, by using new tools and digital solutions.