EMBRACE

2023

Atrial fibrillation (AF) is not benign. It commonly progresses from paroxysmal AF (PAF) to permanent AF. AF progression is associated with major adverse cardiovascular/cerebral events (MACCE). Cardiovascular risk factors and comorbidities (CVR) are present long before the first AF episode, causing a progressive atrial cardiomyopathy (ACM). The mechanisms of ACM vary between patients hindering effective AF management. The EmbRACE network now aims to unravel the diversity of mechanisms underlying ACM, identify simple diagnostic tools to identify them, and develop a therapeutic approach to prevent ACM progression.

The Research

Early rhythm-control therapy is one promising intervention to potentially interfere with ACM progression next to CVR management. For a sustained impact we aim to develop care pathways to prevent ACM and AF progression and MACCE. Therefore, we will

identify and validate relevant cellular and molecular determinants of ACM and AF and their clinical surrogate parameters;
develop an in-silico platform to simulate identified mechanisms of ACM and AF and their effects on AF progression and, based on these data, make suggestions for future refinement of ACM therapy;
explore the variety of temporal patterns of PAF as markers of ACM subtypes, demonstrate their prognostic relevance and identify surrogate markers available in clinical practice, based on AI and machine learning;
test in a randomized trial stratified for sex the hypothesis that early AF ablation and optimal CVR management in AF patients with ACM delays ACM progression and reduces MACCE;
explore whether lifestyle management reduces ACM progression, whereas with only rate control ACM progresses;
validate the RACE V AF progression score in real life cohorts and translate this and other knowledge into novel care pathways for AF.

The origin

Atrial fibrillation is the most common cardiac arrhythmia and can lead to a variety of complications, such as stroke. Currently, there are limited treatment options for this cardiac arrhythmia. Moreover, the disease is often noticed late, which makes proper treatment even more difficult. Therefore, the Dutch Heart Foundation funded the RACE V consortium. Afterwards, the Dutch Heart Foundation guided an exploration to form a national consortium as a follow-up around this theme. This led to the EmbRACE consortium, which is a national network of six university medical centers, UMC Groningen, Maastricht UMC+, UMC Utrecht, Amsterdam UMC and LUMC and Erasmus MC, and hospitals in Arnhem and Eindhoven. The Dutch Heart Foundation funds the research.

Funded

Principal investigators

Prof. U. Schotten (Uli)

Prof. dr. M. Rienstra (Michiel)

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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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BENEFIT

2017

A healthy lifestyle underlies adequate cardiovascular risk management. However, current initiatives to promote a healthy lifestyle are only sparsely connected and often do not involve the patient's environment. To solve this, cardiologists, neurologists, general practitioners, scientists, entrepreneurs, and patients have united in the BENEFIT project.
The research 
Our mission is to make healthy living fun. Rather than telling people how to behave, we make healthy lifestyle choices appealing: the carrot is mightier than the stick. BENEFIT is an advanced loyalty program that rewards cardiovascular patients for the time and energy spent on healthy lifestyle activities. BENEFIT loyalty points can be earned for a range of health behaviors, such as exercising daily, abstaining from smoking, attending prevention programs, and showing up for health appointments. The BENEFIT program has different levels, ranging from a simple to use card-and-beacon system to an advanced digital platform that allows access to evidence-based lifestyle maintenance interventions, personal coaching, and smart technology. By rewarding everyday lifestyle and adherence behaviors, the program integrates care and non-care settings and facilitates embedding the new lifestyle in everyday life.
Our goal is to create a national ecosystem in which evidence-based interventions to promote a healthy lifestyle are embedded in a system that rewards people for taking actions that contribute to such a healthy lifestyle. The central element of this ecosystem is a sophisticated loyalty program that encourages people to live healthy lifestyles for the long term. No more finger-pointing: the very act of rewarding a healthy lifestyle is stimulating! The ecosystem that we provide connects public and private parties, integrates existing care and lifestyle programs, has future-proof financing, and is constantly fed by scientific insights. BENEFIT for all!
The origin
The BENEFIT program is a public-private ecosystem in a national consortium, aiming to support patients with cardiovascular disease in their own home setting for a long-term healthy lifestyle. 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 research agenda. Therefore, the Dutch Heart Foundation and ZonMw have collaborated to fund this program.

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