The Lancet. Respiratory medicineReview
05 May 2025
Despite substantial advancements in the management of cardiogenic shock, mortality rates remain greater than 40%. Trials have shown that increasing survival rates in cardiogenic shock is challenging.
Even the most successful trials show 5-15% reductions in mortality, and gains have been restricted to acute myocardial infarction cardiogenic shock, representing approximately 5% of the population with cardiogenic shock.
Trials studying pharmacological strategies in all populations with cardiogenic shock have been consistently neutral or negative.
The reasons are complex and include heterogeneity in cardiogenic shock phenotypes, timing of patient inclusion, high prevalence of multiorgan failure and cardiac arrest, and unrealistic estimated treatment effects that restrict sample size with sometimes inadequate funding leading to underpowered trials.
In June, 2024, international experts from the fields of cardiology, anaesthesiology, critical care medicine, biostatistics, government regulation of trials, and patient advocacy convened at the sixth Critical Care Clinical Trialists Workshop to reflect on how to improve the design of future randomised clinical trials in cardiogenic shock.
This Position Paper summarises the results of discussions regarding what an optimal randomised controlled trial on cardiogenic shock should entail in terms of population selection, primary objectives, statistical analysis, and incorporation of the patient's perspective.
Declaration of interests AK participated on a Data Safety Monitoring Board or Advisory Board for the LEVOSAH trial and PROCARD trial; and received financial support for attending meetings, travel, or both for the Critical Care Clinical Trialists Workshop 2024. FAW received financial or research support from the Foundation for Cardiovascular Research—Zurich Heart House, Kurt und Senta Herrmann Foundation, Theodor und Ida Herzog-Egli Stiftung, Research Funding for excellent research by the University of Zurich, Fonds zur Förderung des akademischen Nachwuchses of the University of Zurich, Amgen Switzerland, European Society of Cardiology, Swiss Society of Cardiology, Swiss Heart Foundation, Medical University of Graz, 4TEEN4 Pharmaceuticals, PAM Theragnostics, and Sphingotec. JP received grants or contracts from the Schwiete Foundation, German Cardiac Society, German Foundation for Heart Research, and Maquet Cardiopulmonary. JEM received grant from Abiomed and the Novo Nordisk Foundation; consulting fees from Boston Scientific; payment or honoraria for lectures from Abbott and Boehringer Ingelheim; and received equipment from Abiomed. AC received payment or honoraria for lectures from Baxter, Freseniuis, and GETINGE. NS received payment or honoraria for lectures from Abiomed and Terumo. AS received consulting fees from Sanofi; honoraria for lectures from Sanofi; and received equipment for translational research, gifts, or other services from Daiichi-Sankyo. SP is Vice President of the European Society of Cardiology (unpaid); a member of the Resuscitation Committee UK (unpaid); and a Board Member for the European Society of Cardiology (unpaid). REM received honoraria or consulting fees from Roche, Merck, Abiomed, 4TEEN4, Duke Clinical Research Institute, and Weill Cornell Medicine. AM received grants from Roche, 4teen4, Sphyngotec, Abbott Diagnostics, Windtree; consulting fees from Roche, Adrenomed, Corteria, Fire-1, and Johnson&Johnson; is co-inventor of a patent (owned by S-Form Pharma) on combined therapies to treat dyspnoea in heart failure; participated on a Data Safety Monitoring Board or Advisory Board for SECRET-HF, sponsored by the French Government, for S-Form, SunWaves, and Implicity; received honorarium for lectures from Merck, Novartis, Roche, and Bayer; and received equipment from Sphyngotec. All other authors declare no competing interests.
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