Heart failure (HF) is a pandemic currently affecting up to 15 million people in Europe. It is a complex clinical syndrome presenting with impaired heart function and is associated with poor quality of life for patients and high healthcare costs. There is a high clinical demand for novel artificial intelligence (AI) tools which will facilitate risk stratification, early diagnosis, and disease progression assessment in HF. Such tools are essential to allow prompt initiation of evidence-based prevention and treatment strategies which will improve patient quality of life, reduce morbidity and mortality and the HF burden on healthcare. STRATIFYHF aims to develop, validate and implement the first AI-based, decision support system (DSS) for risk stratification, early diagnosis, and disease progression assessment in HF to accommodate both primary and secondary care clinical needs. The DSS will integrate patient-specific demographic and clinical data using existing and novel technologies and establish AI-based tools for risk stratification and HF prediction using machine learning. Additionally, a mobile app will be developed to empower patients to better manage their condition, and health care professionals to make informed decision in selection of evidence-based HF prevention and treatment strategies. Our multidisciplinary consortium, including three small-to-medium enterprises (SMEs) and two stakeholder organisations, will be guided by medical advice and regulatory and health technology experts to deliver the DSS as a medical class 2b device, reaching TRL 8 by the end of the project. STARTIFYHF will change the way in which HF is diagnosed today and thereby improve the quality and length of patients’ lives and lead to efficient and sustainable healthcare systems by reducing the number of HF-related hospital admissions and unnecessary referrals from primary to secondary care in Europe and beyond.

The PragmaTIL trial aims to optimize treatment of cancer patients with Tumour-Infiltrating Lymphocytes Adoptive Cell Therapy (TIL-ACT) and substantially expand and improve the clinical implementation of this treatment modality in academic hospitals. To this end, treatment related toxicities, associated to high-dose interleukin 2 (HD-IL-2) required for expansion and activation of TILs will be reduced while maintaining efficacy. This improved tolerability will achieve a better clinical management of patients and enhance their quality of life, both of which represent major barriers for applying this treatment. The objectives of PragmaTIL are: i) To determine whether TIL-ACT using IL-2 analog ANV419 reduces the frequency of Grade 2-4 study-related non-hematological toxicities; ii) To compare the quality of life (QoL) of patients during their hospitalization period, using ANV419 vs HD-IL-2. Also, to compare short and long-term measurements of treatment-related toxicities and QoL co-defined by and for patients and their caregivers; and iii) To develop the health technology assessment (HTA) of TIL-ACT using ANV419, as well as a social return of investment (SROI) analysis. To achieve these objectives, the PragmaTIL project is structured into 6 WP that cover all the requirements to implement the project: WP1) Clinical Trial; WP2) IMPD Coordination, RA and Pharmacovigilance; WP3) Patients as co-researchers and Evaluation of Short- and Long-term PROs; WP4) Health Economics; WP5) SROI, Sustainability and Exploitation; WP6) Scientific Coordination, Project Management, Communication and Dissemination. The global impact of this project will not only reach patients, clinical and translational researchers and policy makers but may help to achieve a better acceptance of these therapies by society at large. This action is part of the Cancer Mission cluster of projects on "Diagnosis and treatment".