GENIUS II

The STRAP consortium aims to reduce the burden of heart disease by early detecting heart disease deterioration, benefiting patients, healthcare workers, and society. This initiative responds to acute needs observed in cardiology clinics, combined with the increasing availability of health tracking technologies. The project focuses on developing a new, AI-powered solution using cost-effective technology to maximize impact on healthcare costs. The Research STRAP is dedicated to developing a comprehensive data collection platform integrating off-the-shelf and cutting-edge self-tracking technologies. This platform empowers patients to measure vital signs at home, eliminating the need for frequent clinic visits and enabling longitudinal data collection on daily activities and emotions. The platform enhances self-tracking adherence through gamification strategies. The project involves developing and evaluating novel diagnostic and prognostic methods through two trials with target groups where notable improvements are achievable and highly impactful: Trial for Elderly Heart Patients: reducing re-hospitalization among elderly heart patients to minimize health deterioration and healthcare costs. Trial at Cardiac Outpatient Clinics: lower costs and enhance the quality of heart disease diagnosis for individuals attending cardiac outpatient clinics. The foundation of the trials is twofold. Establishing a Robust Dataset: creating an interconnected dataset to evaluate digitalized techniques' performance in relation to health records. This dataset incorporates electrocardiography data, stethoscope audio recordings, wrist-worn device activity levels, electronic nose sensor data, and self-reported information via IoT technologies, including parameters like water consumption, sleep patterns, real-time feelings, physiological responses, and overall patient well-being. Employing this diverse dataset, STRAP develops innovative analysis and early diagnosis methods to advance heart disease detection and monitoring. Through these efforts, STRAP aims to implement advanced technologies and data-driven approaches to significantly impact heart disease management. Origin This project was funded within the Big Data & Health Program. The focus of this public-private research program is the use of big data for the early detection and prevention of cardiovascular diseases. The program has been developed by NWO, ZonMw, the Dutch Heart Foundation, the Top Sectors Life Sciences & Health (LSH), ICT and Creative Industry, the Ministry of Health, Welfare and Sport, and the Netherlands eScience Center. Within this research program, the ambitions of the Dutch Heart Foundation, the Ministry of Health, Welfare and Sport, and the Netherlands eScience Center were aligned with the ambitions of Commit2Data for the Top Sectors ICT, LSH, and Creative Industry, as described in the 2018-2019 Kennis- en Innovatiecontracts between NWO and the Top Sectors.

Digoxin is the oldest, market-authorized drug for heart failure (HF), and very cheap. A large trial with digoxin, the DIG trial, executed in the early nineties revealed a highly significant reduction in HF hospitalizations, but no effect on mortality. A post-hoc analysis of the DIG trial suggests that low serum concentrations of digoxin may not only improve HF hospitalizations but also mortality in chronic HF patients. To validate these findings, a prospective, randomized, placebo-controlled trial is required to redefine the role of digoxin in modern HF treatment. The Focus The primary objective of this study is to investigate whether low-level digoxin (targeting serum concentrations of 0.5-0.9 ng/mL), compared to a placebo, reduces (repeated) HF hospitalizations, (repeated) urgent HF hospital visits, and cardiovascular mortality when added to standard guideline-recommended therapies in chronic HF patients with reduced or mid-range ejection fractions (LVEF ≤50%). The Research This proposed trial is a national, multicenter, randomized, double-blind, placebo-controlled clinical trial involving 982 chronic HF patients aged ≥18 years, classified as NYHA II to ambulatory IV, LVEF ≤50%, and specific serum NT-proBNP concentrations based on rhythm and recent HF hospitalization status. Patients must also be on guideline-recommended therapies. The study population includes at least one-third with atrial fibrillation (AF) and one-third women to represent the real-life HF population. Patients were randomized to receive either a low-level digoxin or a placebo in a double-blinded manner. Digoxin Teva will be administered orally, starting at doses of 0.2mg or 0.1mg (based on age, renal function, and concomitant medication). No loading dose is given to the placebo group. After 4 weeks of evaluating medication (digoxin or placebo), concentrations will be measured. Dose adjustments will be made if needed to reach the target serum digoxin concentration range of 0.5-0.9ng/mL. The outcomes in reducing adverse cardiovascular events in patients with chronic heart failure of low-dose digoxin will be compared to the outcomes of the placebo. The origin This study was funded as part of the Dutch Heart Foundation's collaboration with the ZonMw GGG program on Good Use of Medicines (Goed Gebruik Geneesmiddelen) for better treatment of heart failure and atrial fibrillation, which was one of the 5 priority's that the Dutch Heart Foundation set in 2014. The DECISION study involves 38 hospitals and is led by cardiologists from UMC Groningen and the WCN.