PREDICT 2

2019

Sudden cardiac arrest (SCA) remains a significant public health challenge, accounting for nearly 20% of all deaths in developed nations and approximately half of all heart disease-related fatalities. A notable subset of SCA cases occurs in individuals without prior heart disease diagnosis, resulting in profound psychosocial impacts on affected families and society. Ventricular fibrillation (VF) is the primary arrhythmia leading to SCA, often occurring outside healthcare settings with survival rates ranging from 5% to 20%. Prevention is crucial, yet gaps in our understanding of SCA causes and mechanisms hinder effective prevention efforts. Various genetic and non-genetic factors, such as gender, age, comorbidities, and lifestyle, likely influence SCA risk, but their specific contributions remain unclear.

The Focus
The PREDICT2 initiative brings together leading Principal Investigators with expertise in epidemiology, clinical studies, genetics, and functional research to elucidate factors contributing to SCA, uncover underlying mechanisms, and develop strategies for prevention and treatment.

The Research
Building on foundational work from PREDICT1, which involved extensive patient characterization and preclinical model development, PREDICT2 focuses on inherited arrhythmia syndromes as models to understand the arrhythmogenic substrate in more common cardiac syndromes associated with SCA. Specifically, PREDICT2 aims to:

  1. Identify genetic and non-genetic factors that contribute to SCA risk and develop personalized risk prediction algorithms for individual patient assessment.
  2. Conduct functional studies to elucidate the mechanisms underlying SCA, enabling the development of novel risk stratification and therapeutic approaches.
  3. Implement clinical studies to evaluate risk prediction algorithms and therapeutic interventions, aiming to enhance the treatment and prevention of SCA.

Origin
This consortium was funded through the Impulse Grant program by the Dutch Heart Foundation.

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Collaborators

Contact person:

Prof. Dr. A.A. Wilde (Arthur)

Principal investigators

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DECISION

2020
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.
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Supreme Nudge

2017
A healthy lifestyle - a healthy diet and adequate exercise - contribute significantly to chronic disease prevention. People with a lower socioeconomic position (SEP) often have an unhealthier lifestyle than people with a higher SEP. However, interventions aimed at promoting a healthy lifestyle reach precisely this lower SEP target group poorly and may increase social inequality. A possible explanation is that interventions traditionally tend to focus on individual determinants of behavior such as knowledge, attitudes and intentions. Moreover, these interventions are often not effective, partly because they do not take into account the - social, physical and political - context in which lifestyle choices are made: unhealthy behavior can be seen as an automatic reaction to the 'obesogenic' environment. Changes in and of the environment in which people live can go a long way in promoting healthy lifestyles and reaching all target groups. Changes in the environment should ensure that the healthy choice becomes the easy choice, the obvious choice or even the only choice, especially also for the hard to reach and change target groups such as people with lower education. However, whether environmental interventions are also effective in improving cardiovascular disease risk factors in the longer term is not known and needs to be investigated. The Research Supermarkets form one of the most important point-of-choice settings with the potential to directly influence purchasing behaviors. ‘Nudges’ (small environmental encouragements) target the quick, automatic choices and do not require conscious decision making, and pricing strategies can seduce consumers to buy healthier alternatives. Such environmental cues can make it easier to initiate and maintain a healthy lifestyle, and as such, to improve cardiometabolic health. In addition, the use of theory-based mobile applications is an effective way to provide tailored and context-specific feedback on physical activity behaviors through the stimulation of ‘goal setting’ and ‘self-management’. Being incorporated in structures and systems, environmental interventions can make the healthy choice an easy choice for everyone. As such, these types of interventions are especially effective in reaching otherwise difficult-to-reach groups such as people with a lower socioeconomic position (SEP). In particular, a combination of ‘nudging’ (targeting automatic behaviors), ‘pricing’ (responding to the price-sensitivity of low income consumers) and tailored physical activity feedback and support (which works better than general education), seems promising for lowering cardiometabolic risk in individuals with low SEP. Yet, the existing evidence is mostly restricted to short-term effects on (proxies of) health behaviors, and little is known about long-term impact of such integrated interventions on cardiometabolic risk factors. With SUPREME NUDGE we expand a previous successful Dutch supermarket pricing strategy intervention, and incorporate promising elements such as nudging and ICT applications to provide real-time and context-specific physical activity feedback. We will investigate the effects of this approach on dietary behaviors, physical activity and established cardiometabolic risk factors in adults with a lower SEP. Using principles from Participatory Action Research and systems thinking, we will consult with the relevant stakeholders to explore options for upscaling and further implementation in society. Outcomes will provide policy- and practice relevant evidence with clear, stepwise and realistic leverage points for helping individuals to maintain healthy behaviors and improve their cardiometabolic health by making the healthy choice the easy choice. SUPREME NUDGE is coordinated by the Amsterdam UMC, location VU University, and includes partners from the VU University, University of Amsterdam, Utrecht University Medical Center, Utrecht University, the Dutch Nutrition Center, Te Velde Research, Nynke van der Laan (ICT developer), Duwtje (creative designers) and supermarket chain Coop. 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!". SUPREME NUDGE is one of the projects funded from this program.
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