Summary
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use of diuretics, the basic cornerstone of symptoms relief in HFrEF by targeting congestion, is supported by poor and outdated evidence.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.
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.
Unfold all
/
Fold all
More information & hyperlinks
| Web resources: | https://cordis.europa.eu/project/id/101095653 |
| Start date: | 01-10-2023 |
| End date: | 30-09-2028 |
| Total budget - Public funding: | 9 600 663,00 Euro - 9 600 663,00 Euro |
Cordis data
Original description
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.
Status
SIGNEDCall topic
HORIZON-HLTH-2022-TOOL-11-01Update Date
12-03-2024
Images
No images available.
Geographical location(s)
Structured mapping
Unfold all
/
Fold all
Search
Organisations
-
| IRCCS AZIENDA OSPEDALIERO- UNIVERSITARIA DI BOLOGNA (Coördinator)
-
| ACADEMISCH ZIEKENHUIS GRONINGEN
-
| ALMA MATER STUDIORUM-UNIVERSITA DI BOLOGNA
-
| ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
-
| ASSOCIAZIONE ITALIANA SCOMPENSATI CARDIACI ASSOCIAZIONE DI PROMOZIONE SOCIALE
-
| ECRIN EUROPEAN CLINICAL RESEARCH INFRASTRUCTURE NETWORK
-
| ERASMUS UNIVERSITEIT ROTTERDAM
-
| ETHNIKO KAI KAPODISTRIAKO PANEPISTIMIO ATHINON
-
| FACHHOCHSCHULE NORDWESTSCHWEIZ
-
| FONDAZIONE PER IL TUO CUORE ONLUS
-
| FUNDACION PARA LA INVESTIGACION DEL HOSPITAL CLINICO DE LA COMUNITAT VALENCIANA, FUNDACION INCLIVA
-
| I.M.A. INDUSTRIA MACCHINE AUTOMATICHE SPA (IMA)
-
| INSTITUT DE INVESTIGACIO EN CIENCIES DE LA SALUT GERMANS TRIAS I PUJOL
-
| INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
-
| ISTITUTO SUPERIORE DI SANITA