ArticleFrontiers in cardiovascular medicine2026
Early use of levosimendan to improve survival and neurological outcomes after cardiac arrest with myocardial dysfunction: a protocol for a randomized controlled trial.
Article in Frontiers in cardiovascular medicine, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05956431 (A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest), which is not on this map. Not yet cited in PubMed.
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A Randomized Controlled Clinical Study of Early Application of Levosimendan to Improve Cardiac Dysfunction and Neurological Prognosis in Patients With Cardiac Arrest
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5 authors.
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Abstract
Introduction: Post-cardiac arrest myocardial dysfunction (PAMD) is a major contributor to early death (within 72 hours) following return of spontaneous circulation (ROSC). Levosimendan, a calcium-sensitizing inotrope with vasodilatory and mitochondrial-protective properties, offers a potential therapeutic strategy by increasing cardiac output, improving organ perfusion, and attenuating mitochondrial ischemia-reperfusion injury. While experimental evidence suggests multi-organ benefits in cardiac arrest (CA), robust clinical data are lacking. Methods and analysis: This exploratory, partially blinded, randomized, placebo-controlled trial will enroll 60 comatose CA patients with PAMD across three centers in China. Within 180 minutes after ROSC, eligible participants will be randomized (1:1) to receive either intravenous levosimendan (0.05-0.2 μg/kg/min for 24 hours) or volume-matched saline placebo; the assigned infusion will begin within 6 hours after ROSC. The primary outcome is 30-day all-cause mortality, interpreted within an exploratory signal-generating framework. Secondary outcomes explore 30-day neurological recovery assessed by the Cerebral Performance Category (CPC) and Modified Rankin Scale (mRS), along with cardiac function and hemodynamic stability during the first week post-resuscitation. Discussion: This exploratory trial is designed to align early levosimendan infusion (within 6 hours post-ROSC) with its pharmacokinetics to cover the anticipated nadir of myocardial dysfunction. By targeting a homogeneous cohort with witnessed arrest, rapid ROSC (<60 min), and LVEF <40%, the trial focuses on patients with potentially reversible injury who may benefit most. The findings will provide preliminary evidence on efficacy and safety to inform a definitive Phase III trial. Clinical Trial Registration: https://clinicaltrials.gov/study/NCT05956431, ClinicalTrials.gov NCT05956431. Registered on 21 July 2023.
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