HEROES

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.

The best way to maintain a healthy lifestyle for a long time is to teach it young. This certainly applies to those groups where unhealthy behavior is common: lower socioeconomic groups, which are increasingly multi-ethnic. The Research In this program we are studying the causes of unhealthy behavior in ongoing cohort studies, and together with the target group (10-14 years) we are looking for new ways to teach healthy behavior (nutrition, physical activity, sitting and sleeping behavior). We develop innovative interventions that at multiple levels (family, school, neighborhood, city) change the child's environment in such a way that healthy behavior is encouraged and unhealthy behavior is discouraged.  We implement and evaluate in Amsterdam, and disseminate results to other cities. The origin The Heart Foundation aims for more people to make healthy choices, so that they feel vital and run less risk of developing (again) cardiovascular diseases, which was one of the themes of the reserach agenda. With its prevention programs, ZonMw contributes to the improvement of prevention practice, to health gains and to reducing socioeconomic health disparities. Results from research show that healthy behavior cannot be taken for granted, and is strongly influenced by people's social and physical environment and socioeconomic status. Proven effective, innovative and accessible methods to enable people to maintain a healthy lifestyle for a long time are lacking. Therefore, the Dutch Heart Foundation and ZonMw have collaborated to form the program "Gezond leven: goed voor het Hart!". LIKE is one of the projects funded from this program.