BENEFIT

Clinical staff in hospital wards traditionally collect vital signs periodically to assess a patient's cardiorespiratory status, often with intervals of 6 to 10 hours. This method, known as spot-checking, has limitations due to its infrequent nature and dependence on contact sensors, which can be uncomfortable for patients, particularly during sleep. The Focus Recent advancements demonstrate that vital signs like heart rate, respiration rate, blood oxygen saturation, and temperature can be monitored remotely using camera-based methods, which are less invasive compared to contact sensors. This innovation could significantly enhance patient comfort by enabling continuous monitoring without the need for frequent interventions by clinical staff. Continuous monitoring also allows for trend analysis of vital signs, offering a comprehensive assessment of a patient's cardiorespiratory condition. Additionally, camera-based methods enable video context analysis, such as detecting patient movements or identifying pain through facial expression analysis. This project explores the use of continuous video monitoring as an unobtrusive method to predict and monitor patient deterioration or adverse events. The Research Initially, the feasibility and reliability of camera-based continuous monitoring will be evaluated using data from consenting patients in the ICU at Catharina Hospital in Eindhoven and healthy volunteers. Subsequently, robust technologies will be developed to automatically detect signs of patient deterioration by generating automated early warning scores based on measured vital signs. Throughout the project, feedback from clinical staff and patient experiences will inform the design and implementation of camera-based technologies and early warning systems. Origin This project is funded within the Innovative Medical Devices Initiative (IMDI) program 'Heart for Sustainable Care'. The focus of this program is the development of medical technology for the earlier detection, monitoring, and better treatment of cardiovascular diseases to ensure accessible healthcare and sufficient staffing. The program has been developed en funded by the Dutch Heart Foundation, ZonMw and NWO, who collaborate within the Dutch CardioVascular Alliance.

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.