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Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 28, 2026
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Phase 3 Trial.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT04158674). This is a study registration, not published results. Lead sponsor: Centre Hospitalier Universitaire Dijon. Recruitment status: TERMINATED. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 82 participants (ACTUAL). Conditions: Acute Decompensated Heart Failure. Interventions: DRUG: Levosimendan; DRUG: Cernevit. Primary outcome measures: ECLS withdrawal failure , 7 days after ECLS removal. Brief summary: Extracorporeal life support (ECLS) is a circulatory cardio supplementation technique; it therefore makes it possible to compensate for a defective cardiac or cardio-respiratory function. ECLS nevertheless remains a temporary assistance technique pending a potential recovery of cardiac function, or it can be used to direct patients towards a heart transplant or long-term circulatory assistance (Left Ventricular Assist Device (LVAD) or Total Heart). In patients with complete or partial recovery of cardiac and circulatory function, ECLS withdrawal may be considered. Withdrawal from ECLS remains a delicate phase and the risk of failure is high. The mechanism of action of levosimendan, a drug that increases the contractility of the heart, suggests that it would improve the heart-vessel connection and reduce the rate of ECLS withdrawal failure. The effect of levosimendan is maximal 24 to 48 hours after the end of the infusion and has a prolonged period of action. The objective is to evaluate the efficacy of levosimendan administration (0.2 µg/kg/min over 24 hours) - versus placebo - prior to ECLS removal on the rate of withdrawal failure in patients under ECLS.