Dr. Frances O'Brien

European Commission (2021) Purpose: VALIDATION OF ARTIFICIAL MODELS FOR PREDICTING DECOMPENSATIONS AND IMPROVING QUALITY OF LIFE IN HEART FAILURE Topic HORIZON-HLTH-2021-DISEASE-04-04- Clinical validation of AI solutions for treatment and care. VALHALLA's (acronym for the group of contributors) main objective is to refine a proof-of-concept (AI) model previously devised in another patient cohort for prediction of decompensation in Heart Failure (HF) patients in telemonitoring scenarios. The study aims to optimise data capture methods (including evaluation of novel wearable devices for HF telemonitoring) which will be evaluated at different sites and countries. The study will use large-scale clinical validation of the model for HF management, comparing the standard of telecare with the AI-enabled predictive approach in terms of relevant clinical outcomes, to provide clinical evidence for its widespread adoption; to evaluate in terms of healthcare integration, acceptance and cost-effectiveness the feasibility of its incorporation in different settings across different European countries and Colombia; and to prepare for qualification according to regulatory requirements such as the new EU Medical Device Regulation. The outcomes The primary outcome will be the percentage of days lost due to unplanned cardiovascular hospital admissions or death from any cause, comparing remote patient management plus usual care to usual care alone during the individual patient follow-up time. The main secondary outcomes will be all-cause mortality and cardiovascular mortality during the individual patient's follow-up time plus 28 days after the last study visit, to a maximum of 197 days; percentage of days lost due to unplanned cardiovascular hospital admissions, and percentage of days lost due to unplanned heart failure hospital admissions; change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) global score. The PROMs and PREMs, and QoL questionaries will also be measure.

The primary objective of the study is to test the effectiveness of a study-specific blood pressure (B/P) monitor, and a study-specific weighing scales, together with the fluid heart tracker app (triple pack) in patients with heart failure. The secondary objective is to qualitatively assess participants and healthcare providers" perceived usefulness and clinical acceptability of the triple pack.

The objective of CARAMEL is to develop and validate a novel stratified approach for personalized CVD risk assessment and intervention, enabled by a variety of diagnostic technologies and digital data sources, novel molecular and imaging biomarkers and AI-enabled decision support tools, that can better predict and assess individual CVD risk in women aged 40-60 yrs. Based on perceived individual risks, CARAMEL will develop a stratified personalized prevention strategy, based on a self-managed app-based intervention which will be co-created by women and is complemented by the necessary care plans, evidence-based clinical interventions and psychological and community-based support. CVD are often referred as the silent killer and our aim is to unmask and stop this.

The current global COVID-19 pandemic has radically transformed the provision of emergency healthcare in Ireland and represents the greatest medical challenge in decades. With respect to cardiovascular diseases, COVID-19 infection is associated with increased morbidity and mortality in patients with pre-existing cardiovascular disease especially hypertension and coronary heart disease. The fact that patients with cardiovascular disease frequently have underlying medical co-morbidities such as diabetes mellitus, hypertension and obesity, places them at a substantially increased risk for serious complications of COVID-19. This quantitative study will use explore baseline and follow-up data on patients admitted to the research site with COVID-19 between March 2020 and 2021 to determine if there are differences in clinical presentation of COVID-19 and outcomes of COVID-19 over time, between patients with pre-existing cardiovascular disease and risk factors and those with no such history.