Design and rationale of the RISC-Trial: Multicenter R CT to assess I mmediate discharge of S yncope patients admitted to the ( C ardiac) emergency room

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ID: 313419
2026
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Abstract
Abstract Background Syncope is responsible for 1-3% of emergency department presentations. The European Society of Cardiology guidelines on syncope recommend a structured initial evaluation to diagnose syncope patients. If the cause for the syncopal event remains unexplained, risk-stratification is applied to distinguish between patients at high-risk of serious cardiovascular events and low-risk patients, who can be safely discharged. However, there is a group of patients in whom this risk can currently not be adequately determined, hereafter called intermediate-risk. In clinical practice, these patients are either immediately discharged or admitted for 24-hour in-hospital cardiac rhythm-monitoring. Due to the high cost of admission, immediate discharge could lower healthcare-costs, hospital bed utilization and patient burden. To our knowledge, there is not sufficient scientific basis for superiority of either. The RISC-trial aims to resolve this knowledge gap. Study Design The RISC-trial is an investigator-initiated multicenter prospective randomized controlled trial. A total of 640 pre-defined low- and intermediate-risk syncope patients are randomized to either immediate discharge or discharge after 24-hour in-hospital rhythm monitoring (1:1). The trial is powered to claim non-inferiority of immediate discharge with respect to (non-)fatal composite safety-endpoints which entail arrhythmic disorders, syncope recurrence and (cardiovascular)death. Furthermore, healthcare-costs and quality-of-life will be evaluated. Conclusion The RISC-trial is a multicenter RCT that aims to gather scientific evidence for immediate discharge of ESC-guideline based pre-defined low- and intermediate-risk syncope patients in the emergency department. Primary endpoints entail cardiovascular events such as arrhythmias, syncope and death. This trial is registered at ClinicalTrials.gov with trial-ID: NCT06472375.
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Authors T T Boel, S Y G Peeters, A P van Alem, J M J Boogers, M Bootsma, M A van den Dorpel, M Firouzi, J G J Groothuis, M E W Hemels, H J Houtgraaf, W P J Jansen, J S Y de Jong, M Jongenotter, E C A Kaal, E M Koomen, S E Langerak, G Mairuhu, N E Mullaart, J B van Rees, M Samim, E Wierda, S van Zanten, A van Zoelen, M van Barreveld, P M Croon, M G W Dijkgraaf, J G P Tijssen, J R De Groot, F J de Lange
Journal European Heart Journal Open
Year 2026
DOI
10.1093/ehjopen/oeag078
URL
https://doi.org/10.1093/ehjopen/oeag078
Keywords Keywords not found

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