The RACE 9 Observe-AF

2020

Until recently the standard approach of patients with recent-onset atrial fibrillation (AF) involved early cardioversion. In the latest ESC AF guidelines, a delayed cardioversion approach within 48 hours has been added to the recommendations. However, given the self-terminating and recurrent nature of AF, cardioversion may not always be necessary, and rate control medication could suffice to manage symptoms until spontaneous conversion to sinus rhythm occurs.

The Focus
The RACE 9 Observe-AF trial is a multicenter, prospective, randomized, open-label non-inferiority trial comparing a watchful waiting strategy (intervention) to routine care (control) for patients with recent-onset symptomatic AF.

The Research
The watchful waiting approach involves symptom reduction through rate control medication and monitoring for four weeks to await possible spontaneous conversion to sinus rhythm. Routine care consists of either early or delayed cardioversion within 48 hours. The primary endpoint of this non-inferiority study is the presence of sinus rhythm on the ECG after four weeks.

Several stakeholders and potential end-users are closely involved in defining the study deliverables.
An end-user expert committee has been established, consisting of seven patients with a history of arrhythmias, a psychiatrist, a privacy and legal advisor, a cardiologist, an AF nurse, a general practitioner, and two experts in hospital technology implementation. This committee was involved in piloting the device-based rate and rhythm infrastructure, providing feedback for optimization before the study commencement. Additionally, the committee meets regularly to advise investigators on implementing the device-based infrastructure into daily clinical practice post-study.

The study will be conducted across multiple centers in the Netherlands, including UMC Groningen, Radboud UMC, Amsterdam UMC, Alrijne Hospital, VieCuri Medical Centre, Zuyderland Medical Centre, Elisabeth-TweeSteden Hospital, Rijnstate Hospital, Martini Hospital, St. Antonius Hospital, Antonius Hospital, Noordwest Hospitalgroup, Medisch Spectrum Twente, and Maastricht University Medical Center.

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Funded

Contact person:

Prof. dr. H.J.G.M. Crijns

Principal investigators

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MyDigiTwin

Cardiovascular disease (CVD) is the leading global cause of mortality and morbidity, with ischemic heart disease (IHD) representing approximately half of all CVD-related deaths. Precise, personalized risk assessment and treatment recommendations are crucial for addressing the diverse population at risk of CVD. Current standard approaches rely on algorithms that incorporate a limited set of traditional risk factors to estimate CVD and IHD risk. However, significant cardiovascular events often occur in individuals categorized as low risk, underscoring the need for ongoing research to enhance preventive strategies. The Focus The MyDigiTwin initiative aims to provide individuals with personalized insights into their cardiac health, enabling proactive monitoring and management of cardiovascular conditions. This integrated digital health platform empowers individuals to take control of their cardiac health by offering accessible, data-driven insights and tools. The Research MyDigiTwin is a pioneering research initiative focused on revolutionizing cardiac health management by integrating advanced AI technologies with extensive patient data. The development of MyDigiTwin involves harnessing large-scale longitudinal datasets from over 500,000 patients, combined with sophisticated AI algorithms. This approach enables the platform to analyze diverse health parameters and generate tailored recommendations for users based on their unique health profiles. By leveraging AI and comprehensive patient data, MyDigiTwin represents an innovative approach to preventive and personalized healthcare, facilitating early detection and intervention for cardiovascular conditions.
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LoDoCo2

2016
The aim of the LoDoCo2 (Low Dose Colchicine for secondary prevention of cardiovascular disease) trial was to investigate the effect of low dose colchicine (0,5 mg once daily) on the risk of myocardial infarction (fatal or non-fatal), stroke, or the need for coronary bypass or stent placement. While the precise mechanism through which colchicine mitigates major cardiovascular events remains incompletely understood, it is hypothesized that its anti-inflammatory effects contribute to risk reduction among patients with established atherosclerotic disease. LoDoCo2 stands out in several respects. It represents a large-scale randomized clinical trial conducted entirely by a non-academic network of cardiologists and a consortium of pharmaceutical companies with a focus on drug repurposing. This trial underscores the potential value of older, often cost-effective medications in advancing the development of new innovative drugs. The Research Following a median follow-up period of 3 years, the addition of colchicine to standard treatment resulted in a 30% reduction in risk of myocardial infarction (fatal or non-fatal), stroke, or the need for coronary bypass or stent placement. Patients treated with colchicine exhibited similar side effects compared to those receiving a placebo. Furthermore, no interactions were found with other commonly used drugs such as (potent) statins. In 2021, certain international guidelines had already incorporated colchicine into the secondary prevention of atherosclerotic cardiovascular disease (ASCVD). Subsequently, in 2023, the Food and Drug Administration (FDA) approved Lodoco® (colchicine) for reducing the risk of myocardial infarction (MI), stroke, coronary revascularization, and cardiovascular (CV) death in adult patients with established atherosclerotic disease or multiple risk factors for CV disease. This approval was based on published data regarding the effects of colchicine on cardiovascular events, along with insights from the LoDoCo2 trial. The LoDoCo2 investigators anticipate that colchicine will become the standard treatment for patients with coronary artery disease.
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